global clinical process: Topics by Science.gov

Sample records for global clinical process

Visual form-processing deficits: a global clinical classification.

PubMed

Unzueta-Arce, J; García-García, R; Ladera-Fernández, V; Perea-Bartolomé, M V; Mora-Simón, S; Cacho-Gutiérrez, J

2014-10-01

Patients who have difficulties recognising visual form stimuli are usually labelled as having visual agnosia. However, recent studies let us identify different clinical manifestations corresponding to discrete diagnostic entities which reflect a variety of deficits along the continuum of cortical visual processing. We reviewed different clinical cases published in medical literature as well as proposals for classifying deficits in order to provide a global perspective of the subject. Here, we present the main findings on the neuroanatomical basis of visual form processing and discuss the criteria for evaluating processing which may be abnormal. We also include an inclusive diagram of visual form processing deficits which represents the different clinical cases described in the literature. Lastly, we propose a boosted decision tree to serve as a guide in the process of diagnosing such cases. Although the medical community largely agrees on which cortical areas and neuronal circuits are involved in visual processing, future studies making use of new functional neuroimaging techniques will provide more in-depth information. A well-structured and exhaustive assessment of the different stages of visual processing, designed with a global view of the deficit in mind, will give a better idea of the prognosis and serve as a basis for planning personalised psychostimulation and rehabilitation strategies. Copyright © 2011 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.
Global Health Innovation Technology Models.

PubMed

Harding, Kimberly

2016-01-01

Chronic technology and business process disparities between High Income, Low Middle Income and Low Income (HIC, LMIC, LIC) research collaborators directly prevent the growth of sustainable Global Health innovation for infectious and rare diseases. There is a need for an Open Source-Open Science Architecture Framework to bridge this divide. We are proposing such a framework for consideration by the Global Health community, by utilizing a hybrid approach of integrating agnostic Open Source technology and healthcare interoperability standards and Total Quality Management principles. We will validate this architecture framework through our programme called Project Orchid. Project Orchid is a conceptual Clinical Intelligence Exchange and Virtual Innovation platform utilizing this approach to support clinical innovation efforts for multi-national collaboration that can be locally sustainable for LIC and LMIC research cohorts. The goal is to enable LIC and LMIC research organizations to accelerate their clinical trial process maturity in the field of drug discovery, population health innovation initiatives and public domain knowledge networks. When sponsored, this concept will be tested by 12 confirmed clinical research and public health organizations in six countries. The potential impact of this platform is reduced drug discovery and public health innovation lag time and improved clinical trial interventions, due to reliable clinical intelligence and bio-surveillance across all phases of the clinical innovation process.
Global Health Innovation Technology Models

PubMed Central

Harding, Kimberly

2016-01-01

Chronic technology and business process disparities between High Income, Low Middle Income and Low Income (HIC, LMIC, LIC) research collaborators directly prevent the growth of sustainable Global Health innovation for infectious and rare diseases. There is a need for an Open Source-Open Science Architecture Framework to bridge this divide. We are proposing such a framework for consideration by the Global Health community, by utilizing a hybrid approach of integrating agnostic Open Source technology and healthcare interoperability standards and Total Quality Management principles. We will validate this architecture framework through our programme called Project Orchid. Project Orchid is a conceptual Clinical Intelligence Exchange and Virtual Innovation platform utilizing this approach to support clinical innovation efforts for multi-national collaboration that can be locally sustainable for LIC and LMIC research cohorts. The goal is to enable LIC and LMIC research organizations to accelerate their clinical trial process maturity in the field of drug discovery, population health innovation initiatives and public domain knowledge networks. When sponsored, this concept will be tested by 12 confirmed clinical research and public health organizations in six countries. The potential impact of this platform is reduced drug discovery and public health innovation lag time and improved clinical trial interventions, due to reliable clinical intelligence and bio-surveillance across all phases of the clinical innovation process.
Effective Strategies for Global Health Research, Training and Clinical Care: A Narrative Review

PubMed Central

Walker, Rebekah J.; Campbell, Jennifer A.; Egede, Leonard E.

2015-01-01

The purpose of this narrative review was to synthesize the evidence on effective strategies for global health research, training and clinical care in order to identify common structures that have been used to guide program development. A Medline search from 2001 to 2011 produced 951 articles, which were reviewed and categorized. Thirty articles met criteria to be included in this review. Eleven articles discussed recommendations for research, 8 discussed training and 11 discussed clinical care. Global health program development should be completed within the framework of a larger institutional commitment or partnership. Support from leadership in the university or NGO, and an engaged local community are both integral to success and sustainability of efforts. It is also important for program development to engage local partners from the onset, jointly exploring issues and developing goals and objectives. Evaluation is a recommended way to determine if goals are being met, and should include considerations of sustainability, partnership building, and capacity. Global health research programs should consider details regarding the research process, context of research, partnerships, and community relationships. Training for global health should involve mentorship, pre-departure preparation of students, and elements developed to increase impact. Clinical care programs should focus on collaboration, sustainability, meeting local needs, and appropriate process considerations. PMID:25716404
Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations.

PubMed

Rosemann, Achim; Bortz, Gabriela; Vasen, Federico; Sleeboom-Faulkner, Margaret

2016-10-01

In this article, we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the EU.
Impairment in local and global processing and set-shifting in body dysmorphic disorder

PubMed Central

Kerwin, Lauren; Hovav, Sarit; Helleman, Gerhard; Feusner, Jamie D.

2014-01-01

Body dysmorphic disorder (BDD) is characterized by distressing and often debilitating preoccupations with misperceived defects in appearance. Research suggests that aberrant visual processing may contribute to these misperceptions. This study used two tasks to probe global and local visual processing as well as set shifting in individuals with BDD. Eighteen unmedicated individuals with BDD and 17 non-clinical controls completed two global-local tasks. The embedded figures task requires participants to determine which of three complex figures contained a simpler figure embedded within it. The Navon task utilizes incongruent stimuli comprised of a large letter (global level) made up of smaller letters (local level). The outcome measures were response time and accuracy rate. On the embedded figures task, BDD individuals were slower and less accurate than controls. On the Navon task, BDD individuals processed both global and local stimuli slower and less accurately than controls, and there was a further decrement in performance when shifting attention between the different levels of stimuli. Worse insight correlated with poorer performance on both tasks. Taken together, these results suggest abnormal global and local processing for non-appearance related stimuli among BDD individuals, in addition to evidence of poor set-shifting abilities. Moreover, these abnormalities appear to relate to the important clinical variable of poor insight. Further research is needed to explore these abnormalities and elucidate their possible role in the development and/or persistence of BDD symptoms. PMID:24972487
Laboratory and software applications for clinical trials: the global laboratory environment.

PubMed

Briscoe, Chad

2011-11-01

The Applied Pharmaceutical Software Meeting is held annually. It is sponsored by The Boston Society, a not-for-profit organization that coordinates a series of meetings within the global pharmaceutical industry. The meeting generally focuses on laboratory applications, but in recent years has expanded to include some software applications for clinical trials. The 2011 meeting emphasized the global laboratory environment. Global clinical trials generate massive amounts of data in many locations that must be centralized and processed for efficient analysis. Thus, the meeting had a strong focus on establishing networks and systems for dealing with the computer infrastructure to support such environments. In addition to the globally installed laboratory information management system, electronic laboratory notebook and other traditional laboratory applications, cloud computing is quickly becoming the answer to provide efficient, inexpensive options for managing the large volumes of data and computing power, and thus it served as a central theme for the meeting.
Global-Local Precedence in the Perception of Facial Age and Emotional Expression by Children with Autism and Other Developmental Disabilities

ERIC Educational Resources Information Center

Gross, Thomas F.

2005-01-01

Global information processing and perception of facial age and emotional expression was studied in children with autism, language disorders, mental retardation, and a clinical control group. Children were given a global-local task and asked to recognize age and emotion in human and canine faces. Children with autism made fewer global responses and…
Individualized Gaussian process-based prediction and detection of local and global gray matter abnormalities in elderly subjects.

PubMed

Ziegler, G; Ridgway, G R; Dahnke, R; Gaser, C

2014-08-15

Structural imaging based on MRI is an integral component of the clinical assessment of patients with potential dementia. We here propose an individualized Gaussian process-based inference scheme for clinical decision support in healthy and pathological aging elderly subjects using MRI. The approach aims at quantitative and transparent support for clinicians who aim to detect structural abnormalities in patients at risk of Alzheimer's disease or other types of dementia. Firstly, we introduce a generative model incorporating our knowledge about normative decline of local and global gray matter volume across the brain in elderly. By supposing smooth structural trajectories the models account for the general course of age-related structural decline as well as late-life accelerated loss. Considering healthy subjects' demography and global brain parameters as informative about normal brain aging variability affords individualized predictions in single cases. Using Gaussian process models as a normative reference, we predict new subjects' brain scans and quantify the local gray matter abnormalities in terms of Normative Probability Maps (NPM) and global z-scores. By integrating the observed expectation error and the predictive uncertainty, the local maps and global scores exploit the advantages of Bayesian inference for clinical decisions and provide a valuable extension of diagnostic information about pathological aging. We validate the approach in simulated data and real MRI data. We train the GP framework using 1238 healthy subjects with ages 18-94 years, and predict in 415 independent test subjects diagnosed as healthy controls, Mild Cognitive Impairment and Alzheimer's disease. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.
Individualized Gaussian process-based prediction and detection of local and global gray matter abnormalities in elderly subjects

PubMed Central

Ziegler, G.; Ridgway, G.R.; Dahnke, R.; Gaser, C.

2014-01-01

Structural imaging based on MRI is an integral component of the clinical assessment of patients with potential dementia. We here propose an individualized Gaussian process-based inference scheme for clinical decision support in healthy and pathological aging elderly subjects using MRI. The approach aims at quantitative and transparent support for clinicians who aim to detect structural abnormalities in patients at risk of Alzheimer's disease or other types of dementia. Firstly, we introduce a generative model incorporating our knowledge about normative decline of local and global gray matter volume across the brain in elderly. By supposing smooth structural trajectories the models account for the general course of age-related structural decline as well as late-life accelerated loss. Considering healthy subjects' demography and global brain parameters as informative about normal brain aging variability affords individualized predictions in single cases. Using Gaussian process models as a normative reference, we predict new subjects' brain scans and quantify the local gray matter abnormalities in terms of Normative Probability Maps (NPM) and global z-scores. By integrating the observed expectation error and the predictive uncertainty, the local maps and global scores exploit the advantages of Bayesian inference for clinical decisions and provide a valuable extension of diagnostic information about pathological aging. We validate the approach in simulated data and real MRI data. We train the GP framework using 1238 healthy subjects with ages 18–94 years, and predict in 415 independent test subjects diagnosed as healthy controls, Mild Cognitive Impairment and Alzheimer's disease. PMID:24742919
Global/local processing style: Explaining the relationship between trait anxiety and binge eating.

PubMed

Becker, Kendra R; Plessow, Franziska; Coniglio, Kathryn A; Tabri, Nassim; Franko, Debra L; Zayas, Lazaro V; Germine, Laura; Thomas, Jennifer J; Eddy, Kamryn T

2017-11-01

Anxiety is a risk factor for disordered eating, but the mechanisms by which anxiety promotes disordered eating are poorly understood. One possibility is local versus global cognitive processing style, defined as a relative tendency to attend to details at the expense of the "big picture." Anxiety may narrow attention, in turn, enhancing local and/or compromising global processing. We examined relationships between global/local processing style, anxiety, and disordered eating behaviors in a transdiagnostic outpatient clinical sample. We hypothesized that local (vs. global) processing bias would mediate the relationship between anxiety and disordered eating behaviors. Ninety-three participants completed the eating disorder examination-questionnaire (EDE-Q), State-Trait Anxiety Inventory (STAI)-trait subscale, and the Navon task (a test of processing style in which large letters are composed of smaller letters both congruent and incongruent with the large letter). The sample was predominantly female (95%) with a mean age of 27.4 years (SD = 12.1 years). Binge eating, but not fasting, purging, or excessive exercise, was correlated with lower levels of global processing style. There was a significant indirect effect between anxiety and binge eating via reduced global level global/local processing. In individuals with disordered eating, being more generally anxious may encourage a detailed-oriented bias, preventing individuals from maintaining the bigger picture and making them more likely to engage in maladaptive behaviors (e.g., binge eating). © 2017 Wiley Periodicals, Inc.
Global/local processing style: Explaining the relationship between trait anxiety and binge eating

PubMed Central

Becker, Kendra R.; Plessow, Franziska; Coniglio, Kathryn A.; Tabri, Nassim; Franko, Debra L; Zayas, Lazaro V.; Germine, Laura; Thomas, Jennifer J.; Eddy, Kamryn T.

2018-01-01

Objective Anxiety is a risk factor for disordered eating, but the mechanisms by which anxiety promotes disordered eating are poorly understood. One possibility is local versus global cognitive processing style, defined as a relative tendency to attend to details at the expense of the “big picture.” Anxiety may narrow attention, in turn, enhancing local and/or compromising global processing. We examined relationships between global/local processing style, anxiety, and disordered eating behaviors in a transdiagnostic outpatient clinical sample. We hypothesized that local (vs. global) processing bias would mediate the relationship between anxiety and disordered eating behaviors. Method Ninety-three participants completed the eating disorder examination—questionnaire (EDE-Q), State-Trait Anxiety Inventory (STAI)—trait subscale, and the Navon task (a test of processing style in which large letters are composed of smaller letters both congruent and incongruent with the large letter). The sample was predominantly female (95%) with a mean age of 27.4 years (SD = 12.1 years). Results Binge eating, but not fasting, purging, or excessive exercise, was correlated with lower levels of global processing style. There was a significant indirect effect between anxiety and binge eating via reduced global level global/local processing. Discussion In individuals with disordered eating, being more generally anxious may encourage a detailed-oriented bias, preventing individuals from maintaining the bigger picture and making them more likely to engage in maladaptive behaviors (e.g., binge eating). PMID:28963792
The process and challenges of obtaining and sustaining clinical placements for nursing and allied health students.

PubMed

Taylor, Christine; Angel, Liz; Nyanga, Lucy; Dickson, Cathy

2017-10-01

To describe the process and challenges from a project that aimed to develop processes, source new placements and place students primarily in the discipline of nursing, but also occupational therapy, physiotherapy, podiatry, social work, and speech therapy. Clinical experience in health facilities is an essential element of health professional education, yet globally, there is a lack of clinical placements to meet demands. Educational providers are seeking placements in nontraditional facilities, yet little has been reported on the challenges in the process of procuring clinical placements. The project used a descriptive approach within a quality implementation framework. The project was guided by the quality implementation framework that included four critical steps: considerations of the host setting, structuring the implementation, supporting the implementation and improving future applications. A total of 115 new student placements were finalised across six health disciplines, including elderly care, nongovernment organisations and general practice. Sixty-two nursing students were placed in the new placements during the project. Challenges included communication, the time-consuming nature of the process and 'gatekeeping' blocks to obtaining placements. Recommendations included the importance of personal interaction in developing and maintaining relationships, and the need for clear communication processes and documentation. Potential areas for research are also given. There is great potential for growth in establishing new placements outside the traditional placement facilities for nursing and allied health and for expanding already existing nonhospital placements. Clinical professional experiences are essential to any nursing or allied health programme. There is an increasing demand for, and global lack of, clinical placements for nursing and allied health students. The results provide nursing and allied health educators and managers a framework for planning clinical placement procurement, and assisting in decision-making and developing strategies and processes for practice. © 2016 John Wiley & Sons Ltd.
New insights into the role of motion and form vision in neurodevelopmental disorders.

PubMed

Johnston, Richard; Pitchford, Nicola J; Roach, Neil W; Ledgeway, Timothy

2017-12-01

A selective deficit in processing the global (overall) motion, but not form, of spatially extensive objects in the visual scene is frequently associated with several neurodevelopmental disorders, including preterm birth. Existing theories that proposed to explain the origin of this visual impairment are, however, challenged by recent research. In this review, we explore alternative hypotheses for why deficits in the processing of global motion, relative to global form, might arise. We describe recent evidence that has utilised novel tasks of global motion and global form to elucidate the underlying nature of the visual deficit reported in different neurodevelopmental disorders. We also examine the role of IQ and how the sex of an individual can influence performance on these tasks, as these are factors that are associated with performance on global motion tasks, but have not been systematically controlled for in previous studies exploring visual processing in clinical populations. Finally, we suggest that a new theoretical framework is needed for visual processing in neurodevelopmental disorders and present recommendations for future research. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.
Construct Validity of an Objective Structured Clinical Examination (OSCE) in Psychiatry: Associations with the Clinical Skills Examination and Other Indicators

ERIC Educational Resources Information Center

Park, Robin S.; Chibnall, John T.; Blaskiewicz, Robert J.; Furman, Gail E.; Powell, Jill K.; Mohr, Clinton J.

2004-01-01

Objective: The construct validity of checklist and global process scores for an objective structured clinical examination (OSCE) in psychiatry was assessed. Multiple regression analysis was used to predict psychiatry OSCE scores from the clinical skills examination, an obstetrics/gynecology (OB/GYN) OSCE, and the National Board of Medical…
Semantic Memory in the Clinical Progression of Alzheimer Disease.

PubMed

Tchakoute, Christophe T; Sainani, Kristin L; Henderson, Victor W

2017-09-01

Semantic memory measures may be useful in tracking and predicting progression of Alzheimer disease. We investigated relationships among semantic memory tasks and their 1-year predictive value in women with Alzheimer disease. We conducted secondary analyses of a randomized clinical trial of raloxifene in 42 women with late-onset mild-to-moderate Alzheimer disease. We assessed semantic memory with tests of oral confrontation naming, category fluency, semantic recognition and semantic naming, and semantic density in written narrative discourse. We measured global cognition (Alzheimer Disease Assessment Scale, cognitive subscale), dementia severity (Clinical Dementia Rating sum of boxes), and daily function (Activities of Daily Living Inventory) at baseline and 1 year. At baseline and 1 year, most semantic memory scores correlated highly or moderately with each other and with global cognition, dementia severity, and daily function. Semantic memory task performance at 1 year had worsened one-third to one-half standard deviation. Factor analysis of baseline test scores distinguished processes in semantic and lexical retrieval (semantic recognition, semantic naming, confrontation naming) from processes in lexical search (semantic density, category fluency). The semantic-lexical retrieval factor predicted global cognition at 1 year. Considered separately, baseline confrontation naming and category fluency predicted dementia severity, while semantic recognition and a composite of semantic recognition and semantic naming predicted global cognition. No individual semantic memory test predicted daily function. Semantic-lexical retrieval and lexical search may represent distinct aspects of semantic memory. Semantic memory processes are sensitive to cognitive decline and dementia severity in Alzheimer disease.
Transcultural Endocrinology: Adapting Type-2 Diabetes Guidelines on a Global Scale.

PubMed

Nieto-Martínez, Ramfis; González-Rivas, Juan P; Florez, Hermes; Mechanick, Jeffrey I

2016-12-01

Type-2 diabetes (T2D) needs to be prevented and treated effectively to reduce its burden and consequences. White papers, such as evidence-based clinical practice guidelines (CPG) and their more portable versions, clinical practice algorithms and clinical checklists, may improve clinical decision-making and diabetes outcomes. However, CPG are underused and poorly validated. Protocols that translate and implement these CPG are needed. This review presents the global dimension of T2D, details the importance of white papers in the transculturalization process, compares relevant international CPG, analyzes cultural variables, and summarizes translation strategies that can improve care. Specific protocols and algorithmic tools are provided. Copyright © 2016 Elsevier Inc. All rights reserved.
Distance Learning Methodologies. TRANSCOM Regulating and Command & Control Evacuation System (TRAC2ES).

ERIC Educational Resources Information Center

Bloomquist, Carroll R.

The TRANSCOM (Transportation Command) Regulating Command and Control Evacuation System (TRAC2ES), which applies state-of-the-art technology to manage global medical regulating (matching patients to clinical availability) and medical evacuation processes, will be installed at all Department of Defense medical locations globally. A combination of…
Changing roles of academic societies due to globalization.

PubMed

Ehara, Shigeru; Aoki, Shigeki; Honda, Hiroshi

2016-10-01

Because of the globalization of environment around the academic society, the expected roles have changed significantly. In this short communication, we present the current situation in our international activities of the Japan Radiological Society, particularly in the academic activities and clinical practice. Establishing and reinforcing international network is one process of their promotion.
Local and global processing of music in high-functioning persons with autism: beyond central coherence?

PubMed

Mottron, L; Peretz, I; Ménard, E

2000-11-01

A multi-modal abnormality in the integration of parts and whole has been proposed to account for a bias toward local stimuli in individuals with autism (Frith, 1989; Mottron & Belleville, 1993). In the current experiment, we examined the utility of hierarchical models in characterising musical information processing in autistic individuals. Participants were 13 high-functioning individuals with autism and 13 individuals of normal intelligence matched on chronological age, nonverbal IQ, and laterality, and without musical experience. The task consisted of same-different judgements of pairs of melodies. Differential local and global processing was assessed by manipulating the level, local or global, at which modifications occurred. No deficit was found in the two measures of global processing. In contrast, the clinical group performed better than the comparison group in the detection of change in nontransposed, contour-preserved melodies that tap local processing. These findings confirm the existence of a "local bias" in music perception in individuals with autism, but challenge the notion that it is accounted for by a deficit in global music processing. The present study suggests that enhanced processing of elementary physical properties of incoming stimuli, as found previously in the visual modality, may also exist in the auditory modality.

Neural signature of the conscious processing of auditory regularities

PubMed Central

Bekinschtein, Tristan A.; Dehaene, Stanislas; Rohaut, Benjamin; Tadel, François; Cohen, Laurent; Naccache, Lionel

2009-01-01

Can conscious processing be inferred from neurophysiological measurements? Some models stipulate that the active maintenance of perceptual representations across time requires consciousness. Capitalizing on this assumption, we designed an auditory paradigm that evaluates cerebral responses to violations of temporal regularities that are either local in time or global across several seconds. Local violations led to an early response in auditory cortex, independent of attention or the presence of a concurrent visual task, whereas global violations led to a late and spatially distributed response that was only present when subjects were attentive and aware of the violations. We could detect the global effect in individual subjects using functional MRI and both scalp and intracerebral event-related potentials. Recordings from 8 noncommunicating patients with disorders of consciousness confirmed that only conscious individuals presented a global effect. Taken together these observations suggest that the presence of the global effect is a signature of conscious processing, although it can be absent in conscious subjects who are not aware of the global auditory regularities. This simple electrophysiological marker could thus serve as a useful clinical tool. PMID:19164526
Attention to Local Health Burden and the Global Disparity of Health Research

PubMed Central

Evans, James A.; Shim, Jae-Mahn; Ioannidis, John P. A.

2014-01-01

Most studies on global health inequality consider unequal health care and socio-economic conditions but neglect inequality in the production of health knowledge relevant to addressing disease burden. We demonstrate this inequality and identify likely causes. Using disability-adjusted life years (DALYs) for 111 prominent medical conditions, assessed globally and nationally by the World Health Organization, we linked DALYs with MEDLINE articles for each condition to assess the influence of DALY-based global disease burden, compared to the global market for treatment, on the production of relevant MEDLINE articles, systematic reviews, clinical trials and research using animal models vs. humans. We then explored how DALYs, wealth, and the production of research within countries correlate with this global pattern. We show that global DALYs for each condition had a small, significant negative relationship with the production of each type of MEDLINE articles for that condition. Local processes of health research appear to be behind this. Clinical trials and animal studies but not systematic reviews produced within countries were strongly guided by local DALYs. More and less developed countries had very different disease profiles and rich countries publish much more than poor countries. Accordingly, conditions common to developed countries garnered more clinical research than those common to less developed countries. Many of the health needs in less developed countries do not attract attention among developed country researchers who produce the vast majority of global health knowledge—including clinical trials—in response to their own local needs. This raises concern about the amount of knowledge relevant to poor populations deficient in their own research infrastructure. We recommend measures to address this critical dimension of global health inequality. PMID:24691431
Attention to local health burden and the global disparity of health research.

PubMed

Evans, James A; Shim, Jae-Mahn; Ioannidis, John P A

2014-01-01

Most studies on global health inequality consider unequal health care and socio-economic conditions but neglect inequality in the production of health knowledge relevant to addressing disease burden. We demonstrate this inequality and identify likely causes. Using disability-adjusted life years (DALYs) for 111 prominent medical conditions, assessed globally and nationally by the World Health Organization, we linked DALYs with MEDLINE articles for each condition to assess the influence of DALY-based global disease burden, compared to the global market for treatment, on the production of relevant MEDLINE articles, systematic reviews, clinical trials and research using animal models vs. humans. We then explored how DALYs, wealth, and the production of research within countries correlate with this global pattern. We show that global DALYs for each condition had a small, significant negative relationship with the production of each type of MEDLINE articles for that condition. Local processes of health research appear to be behind this. Clinical trials and animal studies but not systematic reviews produced within countries were strongly guided by local DALYs. More and less developed countries had very different disease profiles and rich countries publish much more than poor countries. Accordingly, conditions common to developed countries garnered more clinical research than those common to less developed countries. Many of the health needs in less developed countries do not attract attention among developed country researchers who produce the vast majority of global health knowledge--including clinical trials--in response to their own local needs. This raises concern about the amount of knowledge relevant to poor populations deficient in their own research infrastructure. We recommend measures to address this critical dimension of global health inequality.
Emerging trends in contract research industry in India.

PubMed

Drabu, Sushma; Gupta, Alka; Bhadauria, Anupama

2010-09-01

A Contract Research Organization (CRO) is a service organization that provides support to the pharmaceutical industry and offers a wide range of "outsourced" pharmaceutical research services to aid in R&D process and is thus an essential tool for undertaking clinical trials in the present scenario when high stakes are involved in the drug discovery process. This industry also offers a safe option of investment as the industry is largely recession-proof, with a significant upscale growth. Presently India occupies a very small pie of the global market share in the Clinical Trials Industry but it is estimated to conduct nearly 5% of global clinical trials by 2012. The global CRO industry valued $18 bn in 2008 and the market is expected to grow at an annual rate of 14% between 2009 and 13. Top multinational pharmaceuticals companies are venturing into the Indian business, in collaboration with the Indian Drug Companies. According to a recent study by Mckinsey & Company, the Indian Clinical Research Industry can attract $1.5 bn of revenue from US and EU by 2010. Such an increase in outsourcing from the western countries has led the global pharma companies and Indian entrepreneurs to set up Contract Research Organizations (CROs) in India. To bring this into realization and fulfil the market demand, while simultaneously aiding in improving the country's economical standards and market position, joint and well-coordinated efforts on part of the government, industry, and working professionals are needed in terms of regulatory affairs, audits, transparency in work affairs, garnering patient confidence, and pharmacovigilance. Copyright 2010 Elsevier Inc. All rights reserved.
Exploring resting-state EEG brain oscillatory activity in relation to cognitive functioning in multiple sclerosis.

PubMed

Keune, Philipp M; Hansen, Sascha; Weber, Emily; Zapf, Franziska; Habich, Juliane; Muenssinger, Jana; Wolf, Sebastian; Schönenberg, Michael; Oschmann, Patrick

2017-09-01

Neurophysiologic monitoring parameters related to cognition in Multiple Sclerosis (MS) are sparse. Previous work reported an association between magnetoencephalographic (MEG) alpha-1 activity and information processing speed. While this remains to be replicated by more available electroencephalographic (EEG) methods, also other established EEG markers, e.g. the slow-wave/fast-wave ratio (theta/beta ratio), remain to be explored in this context. Performance on standard tests addressing information processing speed and attention (Symbol-Digit Modalities Test, SDMT; Test of Attention Performance, TAP) was examined in relation to resting-state EEG alpha-1 and alpha-2 activity and the theta/beta ratio in 25MS patients. Increased global alpha-1 and alpha-2 activity and an increased frontal theta/beta ratio (pronounced slow-wave relative to fast-wave activity) were associated with lower SDMT processing speed. In an exploratory analysis, clinically impaired attention was associated with a significantly increased frontal theta/beta ratio whereas alpha power did not show sensitivity to clinical impairment. EEG global alpha power and the frontal theta/beta ratio were both associated with attention. The theta/beta ratio involved potential clinical sensitivity. Resting-state EEG recordings can be obtained during the routine clinical process. The examined resting-state measures may represent feasible monitoring parameters in MS. This notion should be explored in future intervention studies. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.
Pre-departure preparation for international clinical work: a handbook.

PubMed

Edwardson, Jill; Owens, Lauren; Moran, Dane; Aluri, James; Kironji, Antony; Chen, Chi Chiung Grace

2015-08-01

International clinical experiences are increasingly popular among medical students, residents, fellows, and practitioners. Adequate pre-departure training is an integral part of a meaningful, productive, and safe international experience. At Johns Hopkins University School of Medicine, we have developed a pre-departure handbook to assist practitioners in preparing for global health work. The handbook draws from current global health education literature, existing handbooks, and expert experiences, and includes information about logistical and cultural preparations. While a pre-departure handbook cannot serve as a substitute for a comprehensive pre-departure training program, it can be a useful introduction to the pre-departure process.
Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies.

PubMed

Sanchez, Ana M; Denny, Thomas N; O'Gorman, Maurice

2014-07-01

This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of virologic and immunologic testing. Copyright © 2014 Elsevier B.V. All rights reserved.
Reaction time, processing speed and sustained attention in schizophrenia: impact on social functioning.

PubMed

Lahera, Guillermo; Ruiz, Alicia; Brañas, Antía; Vicens, María; Orozco, Arantxa

Previous studies have linked processing speed with social cognition and functioning of patients with schizophrenia. A discriminant analysis is needed to determine the different components of this neuropsychological construct. This paper analyzes the impact of processing speed, reaction time and sustained attention on social functioning. 98 outpatients between 18 and 65 with DSM-5 diagnosis of schizophrenia, with a period of 3 months of clinical stability, were recruited. Sociodemographic and clinical data were collected, and the following variables were measured: processing speed (Trail Making Test [TMT], symbol coding [BACS], verbal fluency), simple and elective reaction time, sustained attention, recognition of facial emotions and global functioning. Processing speed (measured only through the BACS), sustained attention (CPT) and elective reaction time (but not simple) were associated with functioning. Recognizing facial emotions (FEIT) correlated significantly with scores on measures of processing speed (BACS, Animals, TMT), sustained attention (CPT) and reaction time. The linear regression model showed a significant relationship between functioning, emotion recognition (P=.015) and processing speed (P=.029). A deficit in processing speed and facial emotion recognition are associated with worse global functioning in patients with schizophrenia. Copyright © 2017 SEP y SEPB. Publicado por Elsevier España, S.L.U. All rights reserved.
Clinical Research: A Globalized Network

PubMed Central

Richter, Trevor A.

2014-01-01

Clinical research has become increasingly globalized, but the extent of globalization has not been assessed. To describe the globalization of clinical research, we used all (n = 13,208) multinational trials registered at ClinicalTrials.gov to analyzed geographic connections among individual countries. Our findings indicate that 95% (n = 185) of all countries worldwide have participated in multinational clinical research. Growth in the globalization of clinical research peaked in 2009, suggesting that the global infrastructure that supports clinical research might have reached its maximum capacity. Growth in the globalization of clinical research is attributable to increased involvement of non-traditional markets, particularly in South America and Asia. Nevertheless, Europe is the most highly interconnected geographic region (60.64% of global connections), and collectively, Europe, North America, and Asia comprise more than 85% of all global connections. Therefore, while the expansion of clinical trials into non-traditional markets has increased over the last 20 years and connects countries across the globe, traditional markets still dominate multinational clinical research, which appears to have reached a maximum global capacity. PMID:25517976
Weak central coherence in weight-restored adolescent anorexia nervosa: Characteristics and remediation.

PubMed

Weinbach, Noam; Perry, Amit; Sher, Helene; Lock, James D; Henik, Avishai

2017-08-01

Weak central coherence (WCC) refers to a bias towards processing details (local processing) at the expense of paying attention to the bigger picture (global processing). Multiple studies reported WCC in adults with anorexia nervosa (AN). Evidence for WCC in adolescents with AN has been inconsistent. The current study characterizes WCC in weight-restored adolescents with AN (WR-AN) using a direct measure of WCC, and examines whether WCC can be remediated by increasing alertness level-a manipulation that was found useful in enhancing global processing in healthy individuals and clinical populations. 40 adolescents (18 WR-AN and 22 healthy adolescents) performed a global/local processing task (Navon task). Auditory alerting cues that elevate alertness level were integrated into the task. Both groups processed global information faster than local information. However, compared with controls, adolescents with WR-AN were better at ignoring an irrelevant bigger picture while attending to details (smaller global interference) and had greater difficulty ignoring irrelevant details while attending to the bigger picture (larger local interference). These differences were attenuated when adolescents with WR-AN were under a state of high alertness. Additionally, the local interference effect was positively correlated with three independent self-report questionnaires assessing eating disorders symptomatology. This study suggests that abnormal interference by irrelevant global and local information is a central characteristic of WCC in adolescents with WR-AN that cannot be accounted for by enduring illness or malnourishment. Additionally, this study demonstrates that WCC can be temporarily remediated by encouraging a state of high alertness. © 2017 Wiley Periodicals, Inc.
Development trends for new cancer therapeutics and vaccines.

PubMed

Reichert, Janice M; Wenger, Julia B

2008-01-01

Global commercial development of cancer treatments has dramatically increased over the past 15 years. To assess trends in the process, we analyzed data for 1111 candidates that entered clinical study during 1990-2006. Our results show that although the average number of therapeutic candidates entering clinical study per year more than doubled, the US approval success rate was low (8%) during the period. The therapeutics took seven years on average to go through the clinical and US approval phases, but cancer vaccines have yet to gain any US approvals. These results indicate that improvement in the efficiency of the development process for innovative cancer treatments is needed.
The NIAID Division of AIDS enterprise information system: integrated decision support for global clinical research programs

PubMed Central

Gupta, Nitin; Varghese, Suresh; Virkar, Hemant

2011-01-01

The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) Enterprise Information System (DAIDS-ES) is a web-based system that supports NIAID in the scientific, strategic, and tactical management of its global clinical research programs for HIV/AIDS vaccines, prevention, and therapeutics. Different from most commercial clinical trials information systems, which are typically protocol-driven, the DAIDS-ES was built to exchange information with those types of systems and integrate it in ways that help scientific program directors lead the research effort and keep pace with the complex and ever-changing global HIV/AIDS pandemic. Whereas commercially available clinical trials support systems are not usually disease-focused, DAIDS-ES was specifically designed to capture and incorporate unique scientific, demographic, and logistical aspects of HIV/AIDS treatment, prevention, and vaccine research in order to provide a rich source of information to guide informed decision-making. Sharing data across its internal components and with external systems, using defined vocabularies, open standards and flexible interfaces, the DAIDS-ES enables NIAID, its global collaborators and stakeholders, access to timely, quality information about NIAID-supported clinical trials which is utilized to: (1) analyze the research portfolio, assess capacity, identify opportunities, and avoid redundancies; (2) help support study safety, quality, ethics, and regulatory compliance; (3) conduct evidence-based policy analysis and business process re-engineering for improved efficiency. This report summarizes how the DAIDS-ES was conceptualized, how it differs from typical clinical trial support systems, the rationale for key design choices, and examples of how it is being used to advance the efficiency and effectiveness of NIAID's HIV/AIDS clinical research programs. PMID:21816958
The NIAID Division of AIDS enterprise information system: integrated decision support for global clinical research programs.

PubMed

Kagan, Jonathan M; Gupta, Nitin; Varghese, Suresh; Virkar, Hemant

2011-12-01

The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) Enterprise Information System (DAIDS-ES) is a web-based system that supports NIAID in the scientific, strategic, and tactical management of its global clinical research programs for HIV/AIDS vaccines, prevention, and therapeutics. Different from most commercial clinical trials information systems, which are typically protocol-driven, the DAIDS-ES was built to exchange information with those types of systems and integrate it in ways that help scientific program directors lead the research effort and keep pace with the complex and ever-changing global HIV/AIDS pandemic. Whereas commercially available clinical trials support systems are not usually disease-focused, DAIDS-ES was specifically designed to capture and incorporate unique scientific, demographic, and logistical aspects of HIV/AIDS treatment, prevention, and vaccine research in order to provide a rich source of information to guide informed decision-making. Sharing data across its internal components and with external systems, using defined vocabularies, open standards and flexible interfaces, the DAIDS-ES enables NIAID, its global collaborators and stakeholders, access to timely, quality information about NIAID-supported clinical trials which is utilized to: (1) analyze the research portfolio, assess capacity, identify opportunities, and avoid redundancies; (2) help support study safety, quality, ethics, and regulatory compliance; (3) conduct evidence-based policy analysis and business process re-engineering for improved efficiency. This report summarizes how the DAIDS-ES was conceptualized, how it differs from typical clinical trial support systems, the rationale for key design choices, and examples of how it is being used to advance the efficiency and effectiveness of NIAID's HIV/AIDS clinical research programs.
Collaborative Paradigm of Preventive, Personalized, and Precision Medicine With Point-of-Care Technologies.

PubMed

Dhawan, Atam P

2016-01-01

Recent advances in biosensors, medical instrumentation, and information processing and communication technologies (ICT) have enabled significant improvements in healthcare. However, these technologies have been mainly applied in clinical environments, such as hospitals and healthcare facilities, under managed care by well-trained and specialized individuals. The global challenge of providing quality healthcare at affordable cost leads to the proposed paradigm of P reventive, Personalized, and Precision Medicine that requires a seamless use of technology and infrastructure support for patients and healthcare providers at point-of-care (POC) locations including homes, semi or pre-clinical facilities, and hospitals. The complexity of the global healthcare challenge necessitates strong collaborative interdisciplinary synergies involving all stakeholder groups including academia, federal research institutions, industry, regulatory agencies, and clinical communities. It is critical to evolve with collaborative efforts on the translation of research to technology development toward clinical validation and potential healthcare applications. This special issue is focused on technology innovation and translational research for POC applications with potential impact in improving global healthcare in the respective areas. Some of these papers were presented at the NIH-IEEE Strategic Conference on Healthcare Innovations and POC Technologies for Precision Medicine (HI-POCT) held at the NIH on November 9-10, 2015. The papers included in the Special Issue provide a spectrum of critical issues and collaborative resources on translational research of advanced POC devices and ICT into global healthcare environment.
Local and global processing in block design tasks in children with dyslexia or nonverbal learning disability.

PubMed

Cardillo, Ramona; Mammarella, Irene C; Garcia, Ricardo Basso; Cornoldi, Cesare

2017-05-01

Visuo-constructive and perceptual abilities have been poorly investigated in children with learning disabilities. The present study focused on local or global visuospatial processing in children with nonverbal learning disability (NLD) and dyslexia compared with typically-developing (TD) controls. Participants were presented with a modified block design task (BDT), in both a typical visuo-constructive version that involves reconstructing figures from blocks, and a perceptual version in which respondents must rapidly match unfragmented figures with a corresponding fragmented target figure. The figures used in the tasks were devised by manipulating two variables: the perceptual cohesiveness and the task uncertainty, stimulating global or local processes. Our results confirmed that children with NLD had more problems with the visuo-constructive version of the task, whereas those with dyslexia showed only a slight difficulty with the visuo-constructive version, but were in greater difficulty with the perceptual version, especially in terms of response times. These findings are interpreted in relation to the slower visual processing speed of children with dyslexia, and to the visuo-constructive problems and difficulty in using flexibly-experienced global vs local processes of children with NLD. The clinical and educational implications of these findings are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.
Global aphasia without hemiparesis may be caused by blunt head trauma: An adolescent boy with transient aphasia.

PubMed

Şahin, Sevim; Türkdoğan, Dilşad; Hacıfazlıoğlu, Nilüfer Eldeş; Yalçın, Emek Uyur; Eksen, Zehra Yılmaz; Ekinci, Gazanfer

2017-05-01

Global aphasia without hemiparesis is a rare condition often associated with embolic stroke. Posttraumatic causes have not been reported, in the literature, to our knowledge. We report a 15-year old boy with transient global aphasia without hemiparesis due to blunt head trauma. In our case, clinical findings occurred 1week later following head trauma. Emergence of the symptoms after a period of the first mechanical head trauma, draws attention to the importance of secondary process in traumatic brain injury. Copyright © 2016 Elsevier Ltd. All rights reserved.
A Brief History of Vaccines Against Polio.

PubMed

Vashishtha, Vipin M; Kamath, Sachidanand

2016-08-07

Poliomyelitis, a dreaded disease of the last century that had already crippled millions of people across the globe, is now on the verge of eradication thanks mainly to two polio vaccines, inactivated polio vaccine (IPV) and oral polio vaccine (OPV). Ever since their development in late 1950s and early 1960s, the journey of their early development process, clinical trials, licensure and ultimately widespread clinical use in different countries provide a fascinating tale of events. Oral polio vaccine has been the mainstay of global polio eradication initiative (GPEI) in most of the countries. With the advent of 'polio endgame', the focus has now shifted back to IPV. However, there are certain issues associated with global cessation of OPV use and universal implementation of IPV in routine immunization schedules across the globe that need to be dealt with some urgency, before proclaiming the global victory over polio.
Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa)

PubMed Central

Hennig, Michael; Hundt, Ferdinand; Busta, Susanne; Mikus, Stefan; Sanden, Per-Holger; Sörgel, Andrea; Ruppert, Thorsten

2017-01-01

In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight’s evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial. PMID:28163667
Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).

PubMed

Hennig, Michael; Hundt, Ferdinand; Busta, Susanne; Mikus, Stefan; Sanden, Per-Holger; Sörgel, Andrea; Ruppert, Thorsten

2017-01-01

In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight's evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial.
Motivational processes in mild cognitive impairment and Alzheimer's disease: results from the Motivational Reserve in Alzheimer's (MoReA) study.

PubMed

Forstmeier, Simon; Maercker, Andreas

2015-11-17

Brain reserve, i.e., the ability of the brain to tolerate age- and disease-related changes in a way that cognitive function is still maintained, is assumed to be based on the lifelong training of various abilities. The Motivational Reserve in Alzheimer's (MoReA) is a longitudinal study that aims to examine motivational processes as a protective factor in mild Alzheimer's dementia (AD) and mild cognitive impairment (MCI). This paper presents the results of motivational variables, frequency of diagnoses, and prediction of global cognition as well as depression in a one-year longitudinal study. The sample consists of 64 subjects with MCI and 47 subjects with mild AD at baseline. At baseline, the physical/neurological examinations, standard clinical assessment, neuropsychological testing, and assessment of motivational variables were performed. At follow-up (FU) one year later, neuropsychological testing including cognition, functional abilities, behavioral and affective symptoms, and global clinical assessments of severity have been repeated. AD cases have lower motivational capacities as measured with a midlife motivation-related occupational score and informant-reported present motivational processes, but do not differ with regard to delay of gratification (DoG) and self-reported motivational processes. DoG and delay discounting (DD) were relatively stable during the measurement interval. However, 20 % of the MCI cases converted to mild AD at FU, and 17 % of the mild AD cases converted to moderate AD. The rate of depression of Alzheimer's disease was 9 at baseline and 21 % at FU, and the rate of apathy was 7 and 14 %, respectively. Global cognition at FU was mainly predicted by baseline global cognition but also by one of the motivational variables (scenario test). Depression at FU was predicted mainly by two motivational variables (self-reported and informant-reported motivational processes). This research might inform motivation-related strategies for prevention and early intervention with older people or people at risk for AD.

Rapid Globalization of Medical Device Clinical Development Programs in Japan　- The Case of Drug-Eluting Stents.

PubMed

Murakami, Madoka; Suzuki, Yuka; Tominaga, Toshiyoshi

2018-02-23

Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.
Integrating utilization-focused evaluation with business process modeling for clinical research improvement.

PubMed

Kagan, Jonathan M; Rosas, Scott; Trochim, William M K

2010-10-01

New discoveries in basic science are creating extraordinary opportunities to design novel biomedical preventions and therapeutics for human disease. But the clinical evaluation of these new interventions is, in many instances, being hindered by a variety of legal, regulatory, policy and operational factors, few of which enhance research quality, the safety of study participants or research ethics. With the goal of helping increase the efficiency and effectiveness of clinical research, we have examined how the integration of utilization-focused evaluation with elements of business process modeling can reveal opportunities for systematic improvements in clinical research. Using data from the NIH global HIV/AIDS clinical trials networks, we analyzed the absolute and relative times required to traverse defined phases associated with specific activities within the clinical protocol lifecycle. Using simple median duration and Kaplan-Meyer survival analysis, we show how such time-based analyses can provide a rationale for the prioritization of research process analysis and re-engineering, as well as a means for statistically assessing the impact of policy modifications, resource utilization, re-engineered processes and best practices. Successfully applied, this approach can help researchers be more efficient in capitalizing on new science to speed the development of improved interventions for human disease.
The IND application.

PubMed

Ferkany, John W; Williams, Michael

2008-09-01

Translational biomedical research is often directed to the introduction of a new drug or biologic intended to treat unmet medical need in humans. This unit describes the timing and content of the investigational new drug (IND) application, the primary document required by the U.S. FDA for the initiation of clinical trials in humans with any new chemical entity (NCE) or biologic. The IND application contains all the information necessary for the FDA to make an assessment of the risks and benefits of the proposed clinical trials for the NCE/biologic, containing a detailed but succinct description of the biology, safety, toxicology, chemistry and manufacturing process, and the proposed clinical plan. This unit is geared for those with little or no experience with the IND process and is intended as a global introduction to this, the initial stage of the drug development process for drugs used in humans.
CDISC SHARE, a Global, Cloud-based Resource of Machine-Readable CDISC Standards for Clinical and Translational Research

PubMed Central

Hume, Samuel; Chow, Anthony; Evans, Julie; Malfait, Frederik; Chason, Julie; Wold, J. Darcy; Kubick, Wayne; Becnel, Lauren B.

2018-01-01

The Clinical Data Interchange Standards Consortium (CDISC) is a global non-profit standards development organization that creates consensus-based standards for clinical and translational research. Several of these standards are now required by regulators for electronic submissions of regulated clinical trials’ data and by government funding agencies. These standards are free and open, available for download on the CDISC Website as PDFs. While these documents are human readable, they are not amenable to ready use by electronic systems. CDISC launched the CDISC Shared Health And Research Electronic library (SHARE) to provide the standards metadata in machine-readable formats to facilitate the automated management and implementation of the standards. This paper describes how CDISC SHARE’S standards can facilitate collecting, aggregating and analyzing standardized data from early design to end analysis; and its role as a central resource providing information systems with metadata that drives process automation including study setup and data pipelining. PMID:29888049
Recombinant Human Insulin in Global Diabetes Management – Focus on Clinical Efficacy

PubMed Central

Mbanya, Jean Claude; Sandow, Juergen; Landgraf, Wolfgang

2017-01-01

Abstract Biosynthetic human insulin and insulin analogues are the mainstay of insulin therapy for both type 1 and type 2 diabetes although access to human insulin at affordable prices remains a global issue. The world is experiencing an exponential rise in the prevalence of diabetes presenting an urgent need to establish effective diabetes therapy in countries burdened by inadequate health care budgets, malnutrition and infectious diseases. Recombinant human insulin has replaced animal insulins and animal-based semisynthetic human insulin thereby available in sufficient quantities and at affordable prices able to provide global access to insulin therapy. In many patients, analog insulins can offer additional clinical benefit, although at a considerably higher price thus severely restricting availability in low income countries. The approval process for recombinant human insulins (i.e. biosimilars) and analogue insulins is highly variable in the developing countries in contrast to Europe and in North America, where it is well established within a strict regulatory framework. This review aims to discuss the future access to human insulin therapy in a global context with an ever increasing burden of diabetes and significant economic implications. PMID:29632602
Collaborative Paradigm of Preventive, Personalized, and Precision Medicine With Point-of-Care Technologies

PubMed Central

2016-01-01

Recent advances in biosensors, medical instrumentation, and information processing and communication technologies (ICT) have enabled significant improvements in healthcare. However, these technologies have been mainly applied in clinical environments, such as hospitals and healthcare facilities, under managed care by well-trained and specialized individuals. The global challenge of providing quality healthcare at affordable cost leads to the proposed paradigm of P reventive, Personalized, and Precision Medicine that requires a seamless use of technology and infrastructure support for patients and healthcare providers at point-of-care (POC) locations including homes, semi or pre-clinical facilities, and hospitals. The complexity of the global healthcare challenge necessitates strong collaborative interdisciplinary synergies involving all stakeholder groups including academia, federal research institutions, industry, regulatory agencies, and clinical communities. It is critical to evolve with collaborative efforts on the translation of research to technology development toward clinical validation and potential healthcare applications. This special issue is focused on technology innovation and translational research for POC applications with potential impact in improving global healthcare in the respective areas. Some of these papers were presented at the NIH-IEEE Strategic Conference on Healthcare Innovations and POC Technologies for Precision Medicine (HI-POCT) held at the NIH on November 9–10, 2015. The papers included in the Special Issue provide a spectrum of critical issues and collaborative resources on translational research of advanced POC devices and ICT into global healthcare environment. PMID:28560119
Revision of clinical case definitions: influenza-like illness and severe acute respiratory infection

PubMed Central

Qasmieh, Saba; Mounts, Anthony Wayne; Alexander, Burmaa; Besselaar, Terry; Briand, Sylvie; Brown, Caroline; Clark, Seth; Dueger, Erica; Gross, Diane; Hauge, Siri; Hirve, Siddhivinayak; Jorgensen, Pernille; Katz, Mark A; Mafi, Ali; Malik, Mamunur; McCarron, Margaret; Meerhoff, Tamara; Mori, Yuichiro; Mott, Joshua; Olivera, Maria Teresa da Costa; Ortiz, Justin R; Palekar, Rakhee; Rebelo-de-Andrade, Helena; Soetens, Loes; Yahaya, Ali Ahmed; Zhang, Wenqing; Vandemaele, Katelijn

2018-01-01

Abstract The formulation of accurate clinical case definitions is an integral part of an effective process of public health surveillance. Although such definitions should, ideally, be based on a standardized and fixed collection of defining criteria, they often require revision to reflect new knowledge of the condition involved and improvements in diagnostic testing. Optimal case definitions also need to have a balance of sensitivity and specificity that reflects their intended use. After the 2009–2010 H1N1 influenza pandemic, the World Health Organization (WHO) initiated a technical consultation on global influenza surveillance. This prompted improvements in the sensitivity and specificity of the case definition for influenza – i.e. a respiratory disease that lacks uniquely defining symptomology. The revision process not only modified the definition of influenza-like illness, to include a simplified list of the criteria shown to be most predictive of influenza infection, but also clarified the language used for the definition, to enhance interpretability. To capture severe cases of influenza that required hospitalization, a new case definition was also developed for severe acute respiratory infection in all age groups. The new definitions have been found to capture more cases without compromising specificity. Despite the challenge still posed in the clinical separation of influenza from other respiratory infections, the global use of the new WHO case definitions should help determine global trends in the characteristics and transmission of influenza viruses and the associated disease burden. PMID:29403115
Diabetes prevention: global health policy and perspectives from the ground

PubMed Central

Bergman, Michael; Buysschaert, Martin; Schwarz, Peter EH; Albright, Ann; Narayan, KM Venkat; Yach, Derek

2015-01-01

SUMMARY Type 2 diabetes and other noncommunicable diseases are a growing public health challenge globally. An estimated 285 million people, corresponding to 6.4% of the world’s adult population, has diabetes, which is expected to reach 552 million by the International Diabetes Federation in 2030. A much larger segment of the world’s population, approximating 79 million individuals in the USA alone, has prediabetes. Globally, a relatively small percentage of those with diabetes or prediabetes are diagnosed with the potential for developing chronic complications. To address this epidemic, governments, in concert with the private sector, need to set policies that promote healthy nutritional and agricultural policies, favor modifications in the environment that encourage greater physical activity and make prevention affordable for all citizens at high risk. The public health sector has the charge of translating evidence-based findings into practical, accessible and cost-effective programs and monitoring the process to continuously improve prevention initiatives. The clinical sector has the formidable challenge of screening and identifying those at high risk and referring them to accredited intervention programs. There is a need to explore additional cost-effective interventions that are customized to meet individual needs that can be offered at the community and clinical levels. Thus, all three sectors, government, public health and clinical, each have a critical role in this process and by working in a partnership, ought to create the necessary synergies essential for making substantial forays in the prevention of Type 2 diabetes. PMID:26339296
Development and psychometric evaluation of a clinical global impression for schizoaffective disorder scale.

PubMed

Allen, Michael H; Daniel, David G; Revicki, Dennis A; Canuso, Carla M; Turkoz, Ibrahim; Fu, Dong-Jing; Alphs, Larry; Ishak, K Jack; Bartko, John J; Lindenmayer, Jean-Pierre

2012-01-01

The Clinical Global Impression for Schizoaffective Disorder scale is a new rating scale adapted from the Clinical Global Impression scale for use in patients with schizoaffective disorder. The psychometric characteristics of the Clinical Global Impression for Schizoaffective Disorder are described. Content validity was assessed using an investigator questionnaire. Inter-rater reliability was determined with 12 sets of videotaped interviews rated independently by two trained individuals. Test-retest reliability was assessed using 30 randomly selected raters from clinical trials who evaluated the same videos on separate occasions two weeks apart. Convergent and divergent validity and effect size were evaluated by comparing scores between the Clinical Global Impression for Schizoaffective Disorder and the Positive and Negative Syndrome Scale, 21-item Hamilton Rating Scale for Depression, and Young Mania Rating Scale scales using pooled patient data from two clinical trials. Clinical Global Impression for Schizoaffective Disorder scores were then linked to corresponding Positive and Negative Syndrome Scale scores. Content validity was strong. Inter-rater agreement was good to excellent for most scales and subscales (intra-class correlation coefficient ≥ 0.50). Test-retest showed good reproducibility, with intraclass correlation coefficients ranging from 0.444 to 0.898. Spearman correlations between Clinical Global Impression for Schizoaffective Disorder domains and corresponding symptom scales were 0.60 or greater, and effect sizes for Clinical Global Impression for Schizoaffective Disorder overall and domain scores were similar to Positive and Negative Syndrome Scale Young Mania Rating Scale, and 21-item Hamilton Rating Scale for Depression scores. Raters anticipated that the scale might be less effective in distinguishing negative from depressive symptoms, and, in fact, the results here may reflect that clinical reality. Multiple lines of evidence support the reliability and validity of the Clinical Global Impression for Schizoaffective Disorder for studies in schizoaffective disorder.
Quality of clinical trials: A moving target

PubMed Central

Bhatt, Arun

2011-01-01

Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122
Chemistry, manufacturing and control (CMC) and clinical trial technical support for influenza vaccine manufacturers.

PubMed

Wahid, Rahnuma; Holt, Renee; Hjorth, Richard; Berlanda Scorza, Francesco

2016-10-26

With the support of the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, PATH has contributed to the World Health Organization's (WHO's) Global Action Plan for Influenza Vaccines (GAP) by providing technical and clinical assistance to several developing country vaccine manufacturers (DCVMs). GAP builds regionally based independent and sustainable influenza vaccine production capacity to mitigate the overall global shortage of influenza vaccines. The program also ensures adequate influenza vaccine manufacturing capacity in the event of an influenza pandemic. Since 2009, PATH has worked closely with two DCVMs in Vietnam: the Institute of Vaccines and Medical Biologicals (IVAC) and VABIOTECH. Beginning in 2013, PATH also began working with Torlak Institute in Serbia; Instituto Butantan in Brazil; Serum Institute of India Private Ltd. in India; and Changchun BCHT Biotechnology Co. (BCHT) in China. The DCVMs supported under the GAP program all had existing influenza vaccine manufacturing capability and required technical support from PATH to improve vaccine yield, process efficiency, and product formulation. PATH has provided customized technical support for the manufacturing process to each DCVM based on their respective requirements. Additionally, PATH, working with BARDA and WHO, supported several DCVMs in the clinical development of influenza vaccine candidates progressing toward national licensure or WHO prequalification. As a result of the activities outlined in this review, several companies were able to make excellent progress in developing state-of-the-art manufacturing processes and completing early phase clinical trials. Licensure trials are currently ongoing or planned for several DCVMs. Copyright © 2016 Elsevier Ltd. All rights reserved.
Electronic processing of informed consents in a global pharmaceutical company environment.

PubMed

Vishnyakova, Dina; Gobeill, Julien; Oezdemir-Zaech, Fatma; Kreim, Olivier; Vachon, Therese; Clade, Thierry; Haenning, Xavier; Mikhailov, Dmitri; Ruch, Patrick

2014-01-01

We present an electronic capture tool to process informed consents, which are mandatory recorded when running a clinical trial. This tool aims at the extraction of information expressing the duration of the consent given by the patient to authorize the exploitation of biomarker-related information collected during clinical trials. The system integrates a language detection module (LDM) to route a document into the appropriate information extraction module (IEM). The IEM is based on language-specific sets of linguistic rules for the identification of relevant textual facts. The achieved accuracy of both the LDM and IEM is 99%. The architecture of the system is described in detail.
A global regulatory science agenda for vaccines.

PubMed

Elmgren, Lindsay; Li, Xuguang; Wilson, Carolyn; Ball, Robert; Wang, Junzhi; Cichutek, Klaus; Pfleiderer, Michael; Kato, Atsushi; Cavaleri, Marco; Southern, James; Jivapaisarnpong, Teeranart; Minor, Philip; Griffiths, Elwyn; Sohn, Yeowon; Wood, David

2013-04-18

The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products. Regulatory science builds on high-quality basic research, and encompasses at least two broad categories. First, there is laboratory-based regulatory science. Illustrative examples include development of correlates of immunity; or correlates of safety; or of improved product characterization and potency assays. Included in such science would be tools to standardize assays used for regulatory purposes. Second, there is science to develop regulatory processes. Illustrative examples include adaptive clinical trial designs; or tools to analyze the benefit-risk decision-making process of regulators; or novel pharmacovigilance methodologies. Included in such science would be initiatives to standardize regulatory processes (e.g., definitions of terms for adverse events [AEs] following immunization). The aim of a global regulatory science agenda is to transform current national efforts, mainly by well-resourced regulatory agencies, into a coordinated action plan to support global immunization goals. This article provides examples of how regulatory science has, in the past, contributed to improved access to vaccines, and identifies gaps that could be addressed through a global regulatory science agenda. The article also identifies challenges to implementing a regulatory science agenda and proposes strategies and actions to fill these gaps. A global regulatory science agenda will enable regulators, academics, and other stakeholders to converge around transformative actions for innovation in the regulatory process to support global immunization goals. Copyright © 2012 Elsevier Ltd. All rights reserved.
Electronic-nose devices - Potential for noninvasive early disease-detection applications

Treesearch

Alphus Dan Wilson

2017-01-01

Significant progress in the development of portable electronic devices is showing considerable promise to facilitate clinical diagnostic processes. The increasing global trend of shifts in healthcare policies and priorities toward shortening and improving the effectiveness of diagnostic procedures by utilizing non-invasive methods should provide multiple benefits of...
Unfulfilled translation opportunities in industry sponsored clinical trials.

PubMed

Smed, Marie; Getz, Kenneth A

2013-05-01

Knowledge generated by site representatives through their participation in clinical trials is valuable for testing new products in use and obtaining final market approval. The leverage of this important knowledge is however challenged as the former direct relationships between in-house staff in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract Research Organization) and thereby adding another link in the relationships between site and sponsor. These changes are intended to optimize the time-consuming and costly trial phases; however, there is a need to study whether valuable knowledge and experience is compromised in the process. Limited research exists on the full range of clinical practice insights obtained by investigators during and after clinical trials and how well these insights are transferred to study sponsors. This study explores the important knowledge-transfer processes between sites and sponsors and to what extent sites' knowledge gained in clinical trials is utilized by the industry. Responses from 451 global investigative site representatives are included in the study. The analysis of the extensive dataset reveals that the current processes of collaboration between sites and the industry restrict the leverage of valuable knowledge gained by physicians in the process of clinical trials. These restrictions to knowledge-transfer between site and sponsor are further challenged if CRO partners are integrated in the trial process. Copyright © 2013 Elsevier Inc. All rights reserved.
Benefits of Outsourcing Strategy and IT Technology in Clinical Trials.

PubMed

Stamenovic, Milorad; Dobraca, Amra

2017-09-01

Aim of this paper is to describe some of models of outsourcing (numerous and response to different types of risks and increment of quality is based on individual problem and situation). Defining whether to outsource or not and whether to build or buy new information technology (IT) is question for contract research organization (CRO) and Pharma companies dealing with clinical trials, so the aim of this paper is to show business model that could make process of decision making less time consuming, less segmented and more efficient. This paper has a descriptive character, and represents a review of the literature that deals with the described issues. Outsourcing should enable optimal capacity flexibility (technology that is outsourced should be done only optimally not entirely). The goal with CRO partners is to establish equivalent levels of global quality, as extensions of other research and development activities (by unification of standards of performance of alliance partners with best standards of industry). IT is gaining greater significance at each stage of clinical study and represent an inevitable element of the quality of a clinical study (for the purpose of monitoring of clinical site activities, data collection and management, medical monitoring, statistical programming, statistical analysis, clinical study reporting). CROs are able to maximize work within the CRO global development, to support the notion of a fully integrated outsourced company; facilitate the use of similar business processes and norms, reusing established CRO standards and improve CRO operational decision making within outsourced studies by providing consistent and current information across outsourced and in-house activities.
Benefits of Outsourcing Strategy and IT Technology in Clinical Trials

PubMed Central

Stamenovic, Milorad; Dobraca, Amra

2017-01-01

Introduction: Aim of this paper is to describe some of models of outsourcing (numerous and response to different types of risks and increment of quality is based on individual problem and situation). Defining whether to outsource or not and whether to build or buy new information technology (IT) is question for contract research organization (CRO) and Pharma companies dealing with clinical trials, so the aim of this paper is to show business model that could make process of decision making less time consuming, less segmented and more efficient. Material and methods: This paper has a descriptive character, and represents a review of the literature that deals with the described issues. Results: Outsourcing should enable optimal capacity flexibility (technology that is outsourced should be done only optimally not entirely). The goal with CRO partners is to establish equivalent levels of global quality, as extensions of other research and development activities (by unification of standards of performance of alliance partners with best standards of industry). IT is gaining greater significance at each stage of clinical study and represent an inevitable element of the quality of a clinical study (for the purpose of monitoring of clinical site activities, data collection and management, medical monitoring, statistical programming, statistical analysis, clinical study reporting). Conclusion: CROs are able to maximize work within the CRO global development, to support the notion of a fully integrated outsourced company; facilitate the use of similar business processes and norms, reusing established CRO standards and improve CRO operational decision making within outsourced studies by providing consistent and current information across outsourced and in-house activities. PMID:29114116
An informatics model for guiding assembly of telemicrobiology workstations for malaria collaborative diagnostics using commodity products and open-source software.

PubMed

Suhanic, West; Crandall, Ian; Pennefather, Peter

2009-07-17

Deficits in clinical microbiology infrastructure exacerbate global infectious disease burdens. This paper examines how commodity computation, communication, and measurement products combined with open-source analysis and communication applications can be incorporated into laboratory medicine microbiology protocols. Those commodity components are all now sourceable globally. An informatics model is presented for guiding the use of low-cost commodity components and free software in the assembly of clinically useful and usable telemicrobiology workstations. The model incorporates two general principles: 1) collaborative diagnostics, where free and open communication and networking applications are used to link distributed collaborators for reciprocal assistance in organizing and interpreting digital diagnostic data; and 2) commodity engineering, which leverages globally available consumer electronics and open-source informatics applications, to build generic open systems that measure needed information in ways substantially equivalent to more complex proprietary systems. Routine microscopic examination of Giemsa and fluorescently stained blood smears for diagnosing malaria is used as an example to validate the model. The model is used as a constraint-based guide for the design, assembly, and testing of a functioning, open, and commoditized telemicroscopy system that supports distributed acquisition, exploration, analysis, interpretation, and reporting of digital microscopy images of stained malarial blood smears while also supporting remote diagnostic tracking, quality assessment and diagnostic process development. The open telemicroscopy workstation design and use-process described here can address clinical microbiology infrastructure deficits in an economically sound and sustainable manner. It can boost capacity to deal with comprehensive measurement of disease and care outcomes in individuals and groups in a distributed and collaborative fashion. The workstation enables local control over the creation and use of diagnostic data, while allowing for remote collaborative support of diagnostic data interpretation and tracking. It can enable global pooling of malaria disease information and the development of open, participatory, and adaptable laboratory medicine practices. The informatic model highlights how the larger issue of access to generic commoditized measurement, information processing, and communication technology in both high- and low-income countries can enable diagnostic services that are much less expensive, but substantially equivalent to those currently in use in high-income countries.
Global Manufacturing of CAR T Cell Therapy.

PubMed

Levine, Bruce L; Miskin, James; Wonnacott, Keith; Keir, Christopher

2017-03-17

Immunotherapy using chimeric antigen receptor-modified T cells has demonstrated high response rates in patients with B cell malignancies, and chimeric antigen receptor T cell therapy is now being investigated in several hematologic and solid tumor types. Chimeric antigen receptor T cells are generated by removing T cells from a patient's blood and engineering the cells to express the chimeric antigen receptor, which reprograms the T cells to target tumor cells. As chimeric antigen receptor T cell therapy moves into later-phase clinical trials and becomes an option for more patients, compliance of the chimeric antigen receptor T cell manufacturing process with global regulatory requirements becomes a topic for extensive discussion. Additionally, the challenges of taking a chimeric antigen receptor T cell manufacturing process from a single institution to a large-scale multi-site manufacturing center must be addressed. We have anticipated such concerns in our experience with the CD19 chimeric antigen receptor T cell therapy CTL019. In this review, we discuss steps involved in the cell processing of the technology, including the use of an optimal vector for consistent cell processing, along with addressing the challenges of expanding chimeric antigen receptor T cell therapy to a global patient population.
Developing a curriculum framework for global health in family medicine: emerging principles, competencies, and educational approaches.

PubMed

Redwood-Campbell, Lynda; Pakes, Barry; Rouleau, Katherine; MacDonald, Colla J; Arya, Neil; Purkey, Eva; Schultz, Karen; Dhatt, Reena; Wilson, Briana; Hadi, Abdullahel; Pottie, Kevin

2011-07-22

Recognizing the growing demand from medical students and residents for more comprehensive global health training, and the paucity of explicit curricula on such issues, global health and curriculum experts from the six Ontario Family Medicine Residency Programs worked together to design a framework for global health curricula in family medicine training programs. A working group comprised of global health educators from Ontario's six medical schools conducted a scoping review of global health curricula, competencies, and pedagogical approaches. The working group then hosted a full day meeting, inviting experts in education, clinical care, family medicine and public health, and developed a consensus process and draft framework to design global health curricula. Through a series of weekly teleconferences over the next six months, the framework was revised and used to guide the identification of enabling global health competencies (behaviours, skills and attitudes) for Canadian Family Medicine training. The main outcome was an evidence-informed interactive framework http://globalhealth.ennovativesolution.com/ to provide a shared foundation to guide the design, delivery and evaluation of global health education programs for Ontario's family medicine residency programs. The curriculum framework blended a definition and mission for global health training, core values and principles, global health competencies aligning with the Canadian Medical Education Directives for Specialists (CanMEDS) competencies, and key learning approaches. The framework guided the development of subsequent enabling competencies. The shared curriculum framework can support the design, delivery and evaluation of global health curriculum in Canada and around the world, lay the foundation for research and development, provide consistency across programmes, and support the creation of learning and evaluation tools to align with the framework. The process used to develop this framework can be applied to other aspects of residency curriculum development.

Developing a curriculum framework for global health in family medicine: emerging principles, competencies, and educational approaches

PubMed Central

2011-01-01

Background Recognizing the growing demand from medical students and residents for more comprehensive global health training, and the paucity of explicit curricula on such issues, global health and curriculum experts from the six Ontario Family Medicine Residency Programs worked together to design a framework for global health curricula in family medicine training programs. Methods A working group comprised of global health educators from Ontario's six medical schools conducted a scoping review of global health curricula, competencies, and pedagogical approaches. The working group then hosted a full day meeting, inviting experts in education, clinical care, family medicine and public health, and developed a consensus process and draft framework to design global health curricula. Through a series of weekly teleconferences over the next six months, the framework was revised and used to guide the identification of enabling global health competencies (behaviours, skills and attitudes) for Canadian Family Medicine training. Results The main outcome was an evidence-informed interactive framework http://globalhealth.ennovativesolution.com/ to provide a shared foundation to guide the design, delivery and evaluation of global health education programs for Ontario's family medicine residency programs. The curriculum framework blended a definition and mission for global health training, core values and principles, global health competencies aligning with the Canadian Medical Education Directives for Specialists (CanMEDS) competencies, and key learning approaches. The framework guided the development of subsequent enabling competencies. Conclusions The shared curriculum framework can support the design, delivery and evaluation of global health curriculum in Canada and around the world, lay the foundation for research and development, provide consistency across programmes, and support the creation of learning and evaluation tools to align with the framework. The process used to develop this framework can be applied to other aspects of residency curriculum development. PMID:21781319
What's to Be Done About Laboratory Quality? Process Indicators, Laboratory Stewardship, the Outcomes Problem, Risk Assessment, and Economic Value: Responding to Contemporary Global Challenges.

PubMed

Meier, Frederick A; Badrick, Tony C; Sikaris, Kenneth A

2018-02-17

For 50 years, structure, process, and outcomes measures have assessed health care quality. For clinical laboratories, structural quality has generally been assessed by inspection. For assessing process, quality indicators (QIs), statistical monitors of steps in the clinical laboratory total testing, have proliferated across the globe. Connections between structural and process laboratory measures and patient outcomes, however, have rarely been demonstrated. To inform further development of clinical laboratory quality systems, we conducted a selective but worldwide review of publications on clinical laboratory quality assessment. Some QIs, like seven generic College of American Pathologists Q-Tracks monitors, have demonstrated significant process improvement; other measures have uncovered critical opportunities to improve test selection and result management. The College of Pathologists of Australasia Key Indicator Monitoring and Management System has deployed risk calculations, introduced from failure mode effects analysis, as surrogate measures for outcomes. Showing economic value from clinical laboratory testing quality is a challenge. Clinical laboratories should converge on fewer (7-14) rather than more (21-35) process monitors; monitors should cover all steps of the testing process under laboratory control and include especially high-risk specimen-quality QIs. Clinical laboratory stewardship, the combination of education interventions among clinician test orderers and report consumers with revision of test order formats and result reporting schemes, improves test ordering, but improving result reception is more difficult. Risk calculation reorders the importance of quality monitors by balancing three probabilities: defect frequency, weight of potential harm, and detection difficulty. The triple approach of (1) a more focused suite of generic consensus quality indicators, (2) more active clinical laboratory testing stewardship, and (3) integration of formal risk assessment, rather than competing with economic value, enhances it.
Acne severity grading: determining essential clinical components and features using a Delphi consensus.

PubMed

Tan, Jerry; Wolfe, Barat; Weiss, Jonathan; Stein-Gold, Linda; Bikowski, Joseph; Del Rosso, James; Webster, Guy F; Lucky, Anne; Thiboutot, Diane; Wilkin, Jonathan; Leyden, James; Chren, Mary-Margaret

2012-08-01

There are multiple global scales for acne severity grading but no singular standard. Our objective was to determine the essential clinical components (content items) and features (property-related items) for an acne global grading scale for use in research and clinical practice using an iterative method, the Delphi process. Ten acne experts were invited to participate in a Web-based Delphi survey comprising 3 iterative rounds of questions. In round 1, the experts identified the following clinical components (primary acne lesions, number of lesions, extent, regional involvement, secondary lesions, and patient experiences) and features (clinimetric properties, ease of use, categorization of severity based on photographs or text, and acceptance by all stakeholders). In round 2, consensus for inclusion in the scale was established for primary lesions, number, sites, and extent; as well as clinimetric properties and ease of use. In round 3, consensus for inclusion was further established for categorization and acceptance. Patient experiences were excluded and no consensus was achieved for secondary lesions. The Delphi panel consisted solely of the United States (U.S.)-based acne experts. Using an established method for achieving consensus, experts in acne vulgaris concluded that an ideal acne global grading scale would comprise the essential clinical components of primary acne lesions, their quantity, extent, and facial and extrafacial sites of involvement; with features of clinimetric properties, categorization, efficiency, and acceptance. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
Personalized Symptom Goals and Patient Global Impression on Clinical Changes in Advanced Cancer Patients.

PubMed

Mercadante, Sebastiano; Adile, Claudio; Lanzetta, Gaetano; Mystakidou, Kyriaki; Maltoni, Marco; Soares, Luiz Guilherme; De Santis, Stefano; Ferrera, Patrizia; Valenti, Marco; Rosati, Marta; Rossi, Romina; Cortegiani, Andrea; Masedu, Francesco; Marinangeli, Franco; Aielli, Federica

2018-05-16

The aim of this study was to assess the patients' global impression (PGI) after symptom management, as well as the achievement of personalized symptom goals (PSG). The secondary outcome was to assess related factors. Subjects, Materials, and Methods . Advanced cancer patients admitted to palliative care units rated symptom intensity by using the Edmonton Symptom Assessment Score (ESAS) at admission and then after 1 week. For each symptom, patient-reported PGI and PSG, as well as the rate of PSG response, were evaluated. Eight hundred seventy-six patients were taken into consideration for this study. A mean of 1.71-2.16 points was necessary to perceive a bit better improvement of symptom intensity. Most patients had a PSG of ≤3. A statistically significant number of patients achieved their PSG after starting palliative care. Patients with high intensity of ESAS items at admission achieved a more favorable PGI response. In the multivariate analysis, symptom intensity and PSG were the most frequent factors independently associated to a best PGI, whereas high levels of Karnofsky had a lower odd ratio. PSG and PGI seem to be relevant for patients' assessment and decision-making process, translating in terms of therapeutic intervention. Some factors may be implicated in determining the individual target and clinical response. Personalized symptom goals and global impression of change are relevant for patients' assessment and decision-making process, translating in terms of therapeutic intervention. Some factors may be implicated in determining the individual target and clinical response. © AlphaMed Press 2018.
The Burn Wound Microenvironment

PubMed Central

Rose, Lloyd F.; Chan, Rodney K.

2016-01-01

Significance: While the survival rate of the severely burned patient has improved significantly, relatively little progress has been made in treatment or prevention of burn-induced long-term sequelae, such as contraction and fibrosis. Recent Advances: Our knowledge of the molecular pathways involved in burn wounds has increased dramatically, and technological advances now allow large-scale genomic studies, providing a global view of wound healing processes. Critical Issues: Translating findings from a large number of in vitro and preclinical animal studies into clinical practice represents a gap in our understanding, and the failures of a number of clinical trials suggest that targeting single pathways or cytokines may not be the best approach. Significant opportunities for improvement exist. Future Directions: Study of the underlying molecular influences of burn wound healing progression will undoubtedly continue as an active research focus. Increasing our knowledge of these processes will identify additional therapeutic targets, supporting informed clinical studies that translate into clinical relevance and practice. PMID:26989577
Globalization of psychology: Implications for the development of psychology in Ethiopia.

PubMed

Swancott, Rachel; Uppal, Gobinderjit; Crossley, Jon

2014-10-01

The present article reports on the variation of mental health resources across the globe and considers the merits or otherwise of the process of globalization in low- and middle-income countries (LMIC), with a specific emphasis on Ethiopia. Although globalization has gained momentum in recent years, there is a concern that the globalization of Western mental health frameworks is problematic, as these concepts have been developed in a different context and do not accommodate the current diversity in understanding in LMIC countries. The importance of understanding the mental health frameworks of LMIC like Ethiopia, prior to considering if and how aspects of high-income countries (HIC) conceptualizations may be appropriately imported, is therefore reflected upon. Traditional approaches in managing mental health difficulties and possible reasons for the limited engagement with clinical psychology in Ethiopia are considered. Current developments within the fields of mental health and clinical psychology in Ethiopia are discussed, and the need to develop more local research in order to increase understanding and evaluate treatment interventions is recognized. Further consideration and debate by Ethiopian mental health professionals as well as those from HIC are recommended, to promote both reciprocal learning and new local discourses about mental health.
Development and Psychometric Evaluation of a Clinical Global Impression for Schizoaffective Disorder Scale

PubMed Central

Daniel, David G; Revicki, Dennis A; Canuso, Carla M; Turkoz, Ibrahim; Fu, Dong-Jing; Alphs, Larry; Ishak, K. Jack; Bartko, John J; Lindenmayer, Jean-Pierre

2012-01-01

Objective: The Clinical Global Impression for Schizoaffective Disorder scale is a new rating scale adapted from the Clinical Global Impression scale for use in patients with schizoaffective disorder. The psychometric characteristics of the Clinical Global Impression for Schizoaffective Disorder are described. Design: Content validity was assessed using an investigator questionnaire. Inter-rater reliability was determined with 12 sets of videotaped interviews rated independently by two trained individuals. Test-retest reliability was assessed using 30 randomly selected raters from clinical trials who evaluated the same videos on separate occasions two weeks apart. Convergent and divergent validity and effect size were evaluated by comparing scores between the Clinical Global Impression for Schizoaffective Disorder and the Positive and Negative Syndrome Scale, 21-item Hamilton Rating Scale for Depression, and Young Mania Rating Scale scales using pooled patient data from two clinical trials. Clinical Global Impression for Schizoaffective Disorder scores were then linked to corresponding Positive and Negative Syndrome Scale scores. Results: Content validity was strong. Inter-rater agreement was good to excellent for most scales and subscales (intra-class correlation coefficient ≥0.50). Test-retest showed good reproducibility, with intraclass correlation coefficients ranging from 0.444 to 0.898. Spearman correlations between Clinical Global Impression for Schizoaffective Disorder domains and corresponding symptom scales were 0.60 or greater, and effect sizes for Clinical Global Impression for Schizoaffective Disorder overall and domain scores were similar to Positive and Negative Syndrome Scale Young Mania Rating Scale, and 21-item Hamilton Rating Scale for Depression scores. Raters anticipated that the scale might be less effective in distinguishing negative from depressive symptoms, and, in fact, the results here may reflect that clinical reality. Conclusion: Multiple lines of evidence support the reliability and validity of the Clinical Global Impression for Schizoaffective Disorder for studies in schizoaffective disorder. PMID:22347687
Optimizing clinical operations as part of a global emergency medicine initiative in Kumasi, Ghana: application of Lean manufacturing principals to low-resource health systems.

PubMed

Carter, Patrick M; Desmond, Jeffery S; Akanbobnaab, Christopher; Oteng, Rockefeller A; Rominski, Sarah D; Barsan, William G; Cunningham, Rebecca M

2012-03-01

Although many global health programs focus on providing clinical care or medical education, improving clinical operations can have a significant effect on patient care delivery, especially in developing health systems without high-level operations management. Lean manufacturing techniques have been effective in decreasing emergency department (ED) length of stay, patient waiting times, numbers of patients leaving without being seen, and door-to-balloon times for ST-elevation myocardial infarction in developed health systems, but use of Lean in low to middle income countries with developing emergency medicine (EM) systems has not been well characterized. To describe the application of Lean manufacturing techniques to improve clinical operations at Komfo Anokye Teaching Hospital (KATH) in Ghana and to identify key lessons learned to aid future global EM initiatives. A 3-week Lean improvement program focused on the hospital admissions process at KATH was completed by a 14-person team in six stages: problem definition, scope of project planning, value stream mapping, root cause analysis, future state planning, and implementation planning. The authors identified eight lessons learned during our use of Lean to optimize the operations of an ED in a global health setting: 1) the Lean process aided in building a partnership with Ghanaian colleagues; 2) obtaining and maintaining senior institutional support is necessary and challenging; 3) addressing power differences among the team to obtain feedback from all team members is critical to successful Lean analysis; 4) choosing a manageable initial project is critical to influence long-term Lean use in a new environment; 5) data intensive Lean tools can be adapted and are effective in a less resourced health system; 6) several Lean tools focused on team problem-solving techniques worked well in a low-resource system without modification; 7) using Lean highlighted that important changes do not require an influx of resources; and 8) despite different levels of resources, root causes of system inefficiencies are often similar across health care systems, but require unique solutions appropriate to the clinical setting. Lean manufacturing techniques can be successfully adapted for use in developing health systems. Lessons learned from this Lean project will aid future introduction of advanced operations management techniques in low- to middle-income countries. © 2012 by the Society for Academic Emergency Medicine.
Optimizing Clinical Operations as part of a Global Emergency Medicine Initiative in Kumasi, Ghana: Application of Lean Manufacturing Principals to Low Resource Health Systems

PubMed Central

Carter, Patrick M.; Desmond, Jeffery S.; Akanbobnaab, Christopher; Oteng, Rockefeller A.; Rominski, Sarah; Barsan, William G.; Cunningham, Rebecca

2012-01-01

Background Although many global health programs focus on providing clinical care or medical education, improving clinical operations can have a significant effect on patient care delivery, especially in developing health systems without high-level operations management. Lean manufacturing techniques have been effective in decreasing emergency department (ED) length of stay, patient waiting times, numbers of patients leaving without being seen, and door-to-balloon times for ST-elevation myocardial infarction in developed health systems; but use of Lean in low to middle income countries with developing emergency medicine systems has not been well characterized. Objectives To describe the application of Lean manufacturing techniques to improve clinical operations at Komfo Anokye Teaching Hospital in Ghana and to identify key lessons learned to aid future global EM initiatives. Methods A three-week Lean improvement program focused on the hospital admissions process at Komfo Anokye Teaching Hospital was completed by a 14-person team in six stages: problem definition, scope of project planning, value stream mapping, root cause analysis, future state planning, and implementation planning. Results The authors identified eight lessons learned during our use of Lean to optimize the operations of an ED in a global health setting: 1) the Lean process aided in building a partnership with Ghanaian colleagues; 2) obtaining and maintaining senior institutional support is necessary and challenging; 3) addressing power differences among the team to obtain feedback from all team members is critical to successful Lean analysis; 4) choosing a manageable initial project is critical to influence long-term Lean use in a new environment; 5) data intensive Lean tools can be adapted and are effective in a less resourced health system; 6) several Lean tools focused on team problem solving techniques worked well in a low resource system without modification; 7) using Lean highlighted that important changes do not require an influx of resources; 8) despite different levels of resources, root causes of system inefficiencies are often similar across health care systems, but require unique solutions appropriate to the clinical setting. Conclusions Lean manufacturing techniques can be successfully adapted for use in developing health systems. Lessons learned from this Lean project will aid future introduction of advanced operations management techniques in low to middle income countries. PMID:22435868
The synergy of the whole: building a global system for clinical trials to accelerate medicines development.

PubMed

Koski, Greg; Tobin, Mary F; Whalen, Matthew

2014-10-01

The pharmaceutical industry, once highly respected, productive, and profitable, is in the throes of major change driven by many forces, including economics, science, regulation, and ethics. A variety of initiatives and partnerships have been launched to improve efficiency and productivity but without significant effect because they have failed to consider the process as a system. Addressing the challenges facing this complex endeavor requires more than modifications of individual processes; it requires a fully integrated application of systems thinking and an understanding of the desired goals and complex interactions among essential components and stakeholders of the whole. A multistakeholder collaborative effort, led by the Alliance for Clinical Research Excellence and Safety (ACRES), a global nonprofit organization operating in the public interest, is now under way to build a shared global system for clinical research. Its systems approach focuses on the interconnection of stakeholders at critical points of interaction within 4 operational domains: site development and support, quality management, information technology, and safety. The ACRES initiatives, Site Accreditation and Standards, Product Safety Culture, Global Ethical Review and Regulatory Innovation, and Quality Assurance and Safety, focus on building and implementing systems solutions. Underpinning these initiatives is an open, shared, integrated technology (site and optics and quality informatics initiative). We describe the rationale, challenges, progress, and successes of this effort to date and lessons learned. The complexity and fragmentation of the intensely proprietary ecosystem of drug development, challenging regulatory climate, and magnitude of the endeavor itself pose significant challenges, but the economic, social, and scientific rewards will more than justify the effort. An effective alliance model requires a willingness of multiple stakeholders to work together to build a shared system within a noncompetitive space that will have major benefits for all, including better access to medicines, better health, and more productive lives. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.
Cognitive deficits as an endophenotype for anorexia nervosa: an accepted fact or a need for re-examination?

PubMed

Talbot, Amy; Hay, Phillipa; Buckett, Geoffrey; Touyz, Stephen

2015-01-01

To investigate whether impaired set shifting and weak central coherence represent state or trait characteristics and, therefore, candidate endophenotypes of anorexia nervosa (AN). Forty-nine individuals with lifetime AN (24 acutely unwell, 10 weight recovered, and 15 fully recovered) and 43 healthy controls completed the Wisconsin Card Sorting Test (WCST), the Matching Familiar Figures Test, and the Rey Complex Figure Task measuring cognitive flexibility, local processing, and global processing, respectively. Participants also completed questionnaires assessing eating disorder, anxiety and depressive symptoms, obsessional traits, interpersonal functioning, and quality of life. Body mass index was calculated from height and weight measurements. Participants with lifetime AN demonstrated poorer set shifting ability than healthy controls as evidenced by a greater number of perseverative errors on the WCST. When participants were grouped according to illness status, only those in the two recovered groups demonstrated poorer set shifting ability than healthy controls while patients with acute AN performed comparably to all other groups. There were no significant differences between groups on measures of local and global processing. No relationship was found between specific clinical features of AN and cognitive performance. The results of this study are consistent with a global trend toward set shifting difficulties in patients with AN but do not support weak central coherence as a candidate endophenotype for AN. These findings have clinical implications in terms of treatment selection and planning, particularly in relation to the use of cognitive remediation therapy with patients with AN. © 2014 Wiley Periodicals, Inc.
Oral health promotion and education messages in Live.Learn.Laugh. projects.

PubMed

Horn, Virginie; Phantumvanit, Prathip

2014-10-01

The FDI-Unilever Live.Learn.Laugh. phase 2 partnership involved dissemination of the key oral health message of encouraging 'twice-daily toothbrushing with fluoride toothpaste' and education of people worldwide by FDI, National Dental Associations, the Unilever Oral Care global team and local brands. The dissemination and education process used different methodologies, each targeting specific groups, namely: mother and child (Project option A); schoolchildren (Project option B); dentists and patients (Project option C); and specific communities (Project option D). Altogether, the partnership implemented 29 projects in 27 countries. These consisted of educational interventions, evaluations including (in some cases) clinical assessment, together with communication activities at both global and local levels, to increase the reach of the message to a broader population worldwide. The phase 2 experience reveals the strength of such a public-private partnership approach in tackling global oral health issues by creating synergies between partners and optimising the promotion and education process. © 2014 FDI World Dental Federation.
Japan-Specific Key Regulatory Aspects for Development of New Biopharmaceutical Drug Products.

PubMed

Desai, Kashappa Goud; Obayashi, Hirokazu; Colandene, James D; Nesta, Douglas P

2018-03-28

Japan represents the third largest pharmaceutical market in the world. Developing a new biopharmaceutical drug product for the Japanese market is a top business priority for global pharmaceutical companies while aligning with ethical drivers to treat more patients in need. Understanding Japan-specific key regulatory requirements is essential to achieve successful approvals. Understanding the full context of Japan-specific regulatory requirements/expectations is challenging to global pharmaceutical companies due to differences in language and culture. This article summarizes key Japan-specific regulatory aspects/requirements/expectations applicable to new drug development, approval, and postapproval phases. Formulation excipients should meet Japan compendial requirements with respect to the type of excipient, excipient grade, and excipient concentration. Preclinical safety assessments needed to support clinical phases I, II, and III development are summarized. Japanese regulatory authorities have taken appropriate steps to consider foreign clinical data, thereby enabling accelerated drug development and approval in Japan. Other important topics summarized in this article include: Japan new drug application-specific bracketing strategies for critical and noncritical aspects of the manufacturing process, regulatory requirements related to stability studies, release specifications and testing methods, standard processes involved in pre and postapproval inspections, management of postapproval changes, and Japan regulatory authority's consultation services available to global pharmaceutical companies. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Dengue-2 structural proteins associate with human proteins to produce a coagulation and innate immune response biased interactome.

PubMed

Folly, Brenda B; Weffort-Santos, Almeriane M; Fathman, C G; Soares, Luis R B

2011-01-31

Dengue virus infection is a public health threat to hundreds of millions of individuals in the tropical regions of the globe. Although Dengue infection usually manifests itself in its mildest, though often debilitating clinical form, dengue fever, life-threatening complications commonly arise in the form of hemorrhagic shock and encephalitis. The etiological basis for the virus-induced pathology in general, and the different clinical manifestations in particular, are not well understood. We reasoned that a detailed knowledge of the global biological processes affected by virus entry into a cell might help shed new light on this long-standing problem. A bacterial two-hybrid screen using DENV2 structural proteins as bait was performed, and the results were used to feed a manually curated, global dengue-human protein interaction network. Gene ontology and pathway enrichment, along with network topology and microarray meta-analysis, were used to generate hypothesis regarding dengue disease biology. Combining bioinformatic tools with two-hybrid technology, we screened human cDNA libraries to catalogue proteins physically interacting with the DENV2 virus structural proteins, Env, cap and PrM. We identified 31 interacting human proteins representing distinct biological processes that are closely related to the major clinical diagnostic feature of dengue infection: haemostatic imbalance. In addition, we found dengue-binding human proteins involved with additional key aspects, previously described as fundamental for virus entry into cells and the innate immune response to infection. Construction of a DENV2-human global protein interaction network revealed interesting biological properties suggested by simple network topology analysis. Our experimental strategy revealed that dengue structural proteins interact with human protein targets involved in the maintenance of blood coagulation and innate anti-viral response processes, and predicts that the interaction of dengue proteins with a proposed human protein interaction network produces a modified biological outcome that may be behind the hallmark pathologies of dengue infection.
Free and cued memory in relation to biomarker-defined abnormalities in clinically normal older adults and those at risk for Alzheimer's disease.

PubMed

Papp, Kathryn V; Amariglio, Rebecca E; Mormino, Elizabeth C; Hedden, Trey; Dekhytar, Maria; Johnson, Keith A; Sperling, Reisa A; Rentz, Dorene M

2015-07-01

Furthering our understanding of the relationship between amyloidosis (Aβ), neurodegeneration (ND), and cognition is imperative for early identification and early intervention of Alzheimer's disease (AD). However, the subtle cognitive decline differentially associated with each biomarker-defined stage of preclinical AD has yet to be fully characterized. Recent work indicates that different components of memory performance (free and cued recall) may be differentially specific to memory decline in prodromal AD. We sought to examine the relationship between free and cued recall paradigms, in addition to global composites of memory, executive functioning, and processing speed in relation to stages of preclinical AD. A total of 260 clinically normal (CN) older adults (CDR=0) from the Harvard Aging Brain study were grouped according to preclinical AD stages including Stage 0 (Aβ-/ND-), Stage 1 (Aβ+/ND-), Stage 2 (Aβ+/ND+), and suspected non-Alzheimer's associated pathology (SNAP; Aβ-/ND+). General linear models controlling for age, sex, and education were used to assess for stage-based performance differences on cognitive composites of executive functioning, processing speed, and memory in addition to free and cued delayed recall on the Selective Reminding Test (SRT) and Memory Capacity Test (MCT). Global memory performance differed between preclinical stages with Stage 2 performing worse compared with Stage 0. When examining free and cued paradigms by memory test, only the MCT (and not the SRT) revealed group differences. More specifically, Stage 1 was associated with decrements in free recall compared with Stage 0 while Stage 2 was associated with decrements in both free and cued recall. There was a trend for the SNAP group to perform worse on free recall compared with Stage 0. Finally, there was no association between preclinical stage and global composites of executive functioning or processing speed. Clinically normal older adults with underlying evidence of amyloidosis and neurodegeneration exhibit subtle, yet measurable differences in memory performance, but only on a challenging associative test. The sensitivity of free vs. cued memory paradigms may be dependent on preclinical stage such that reduced free recall is associated with amyloidosis alone (Stage 1) while a decline in cued recall may represent progression to amyloidosis and neurodegeneration (Stage 2). These findings may have practical applications for clinical assessment and clinical trial design. Copyright © 2015. Published by Elsevier Ltd.
Free and Cued Memory in relation to Biomarker-Defined Abnormalities in Clinically Normal Older Adults and Those at Risk for Alzheimer’s Disease

PubMed Central

Papp, Kathryn V.; Amariglio, Rebecca E.; Mormino, Elizabeth; Hedden, Trey; Dekhytar, Maria; Johnson, Keith A.; Sperling, Reisa A.; Rentz, Dorene M.

2015-01-01

Objectives Furthering our understanding of the relationship between amyloidosis (Aβ), neurodegeneration (ND), and cognition is imperative for early identification and early intervention of Alzheimer’s disease (AD). However, the subtle cognitive decline differentially associated with each biomarker-defined stage of preclinical AD has yet to be fully characterized. Recent work indicates that different components of memory performance (free and cued recall) may be differentially specific to memory decline in prodromal AD. We sought to examine the relationship between free and cued recall paradigms, in addition to global composites of memory, executive functioning, and processing speed in relation to stages of preclinical AD. Methods A total of 260 clinically normal (CN) older adults (CDR=0) from the Harvard Aging Brain study were grouped according to preclinical AD stages including Stage 0 (Aβ−/ND−), Stage 1 (Aβ+/ND−), Stage 2 (Aβ+/ND+), and suspected non-Alzheimer’s associated pathology (SNAP; Aβ−/ND+). General linear models controlling for age, sex, and education were used to assess for stage-based performance differences on cognitive composites of executive functioning, processing speed, and memory in addition to free and cued delayed recall on the Selective Reminding Test (SRT) and Memory Capacity Test (MCT). Results Global memory performance differed between preclinical stages with Stage 2 performing worse compared with Stage 0. When examining free and cued paradigms by memory test, only the MCT (and not the SRT) revealed group differences. More specifically, Stage 1 was associated with decrements in free recall compared with Stage 0 while Stage 2 was associated with decrements in both free and cued recall. There was a trend for the SNAP group to perform worse on free recall compared with Stage 0. Finally, there was no association between preclinical stage and global composites of executive functioning or processing speed. Conclusions Clinically normal older adults with underlying evidence of amyloidosis and neurodegeneration exhibit subtle, yet measurable differences in memory performance, but only on a challenging associative test. The sensitivity of free vs. cued memory paradigms may be dependent on preclinical stage such that reduced free recall is associated with amyloidosis alone (Stage 1) while a decline in cued recall may represent progression to amyloidosis and neurodegeneration (Stage 2). These findings may have practical applications for clinical assessment and clinical trial design. PMID:26002757
Global left atrial failure in heart failure.

PubMed

Triposkiadis, Filippos; Pieske, Burkert; Butler, Javed; Parissis, John; Giamouzis, Gregory; Skoularigis, John; Brutsaert, Dirk; Boudoulas, Harisios

2016-11-01

The left atrium plays an important role in the maintenance of cardiovascular and neurohumoral homeostasis in heart failure. However, with progressive left ventricular dysfunction, left atrial (LA) dilation and mechanical failure develop, which frequently culminate in atrial fibrillation. Moreover, LA mechanical failure is accompanied by LA endocrine failure [deficient atrial natriuretic peptide (ANP) processing-synthesis/development of ANP resistance) and LA regulatory failure (dominance of sympathetic nervous system excitatory mechanisms, excessive vasopressin release) contributing to neurohumoral overactivity, vasoconstriction, and volume overload (global LA failure). The purpose of the present review is to describe the characteristics and emphasize the clinical significance of global LA failure in patients with heart failure. © 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.
Dancing with the Muses: dissociation and flow.

PubMed

Thomson, Paula; Jaque, S Victoria

2012-01-01

This study investigated dissociative psychological processes and flow (dispositional and state) in a group of professional and pre-professional dancers (n=74). In this study, high scores for global (Mdn=4.14) and autotelic (Mdn=4.50) flow suggest that dancing was inherently integrating and rewarding, although 17.6% of the dancers were identified as possibly having clinical levels of dissociation (Dissociative Experiences Scale-Taxon cutoff score≥20). The results of the multivariate analysis of variance indicated that subjects with high levels of dissociation had significantly lower levels of global flow (p<.05). Stepwise linear regression analyses demonstrated that dispositional flow negatively predicted the dissociative constructs of depersonalization and taxon (p<.05) but did not significantly predict the variance in absorption/imagination (p>.05). As hypothesized, dissociation and flow seem to operate as different mental processes.
The Medical School Admissions Process and Meeting the Public's Health Care Needs: Never the Twain Shall Meet?

PubMed

Cleland, Jennifer

2017-12-19

Medical schools typically assess how good their selection process is using metrics such as students' assessment performance and the academic success of alumni on later indicators of academic ability and clinical competence, such as Royal College of Physicians or specialty board examinations. To address global issues with the maldistribution of doctors and increasing numbers of new medical school graduates choosing not to work in a clinical context requires different measurements of medical school admissions processes, like those related to graduates' career outcomes (e.g., working in underserved regions and/or working in certain specialties). This shift in focus is not straightforward. Medical education is a complex social system where, intentionally or not, medical schools focus on reproducing cultural, historical, and social norms. Simple solutions are often proposed but they are insufficient to address these complex drivers. Instead it is time to step back and think very differently about medical school admissions. In this Invited Commentary, the author proposes new solutions to address these issues, including: bringing in to the medical school selection process the perspectives of other key stakeholders; increasing collaboration and dialogue across these stakeholder groups; changing the performance metrics by which medical schools are assessed in the global education marketplace; and developing and evaluating new selection processes and tools. Medical schools must engage more reflectively and collaboratively in debates about how to align medical school admissions and meeting the health care needs of the public.
Blood/Brain Biomarkers of Inflammation After Stroke and Their Association With Outcome: From C-Reactive Protein to Damage-Associated Molecular Patterns.

PubMed

Bustamante, Alejandro; Simats, Alba; Vilar-Bergua, Andrea; García-Berrocoso, Teresa; Montaner, Joan

2016-10-01

Stroke represents one of the most important causes of disability and death in developed countries. However, there is a lack of prognostic tools in clinical practice to monitor the neurological condition and predict the final outcome. Blood biomarkers have been proposed and studied in this indication; however, no biomarker is currently used in clinical practice. The stroke-related neuroinflammatory processes have been associated with a poor outcome in stroke, as well as with poststroke complications. In this review, we focus on the most studied blood biomarkers of this inflammatory processes, cytokines, and C-reactive protein, evaluating its association with outcome and complications in stroke through the literature, and performing a systematic review on the association of C-reactive protein and functional outcome after stroke. Globally, we identified uncertainty with regard to the association of the evaluated biomarkers with stroke outcome, with little added value on top of clinical predictors such as age or stroke severity, which makes its implementation unlikely in clinical practice for global outcome prediction. Regarding poststroke complications, despite being more practical scenarios in which to make medical decisions following a biomarker prediction, not many studies have been performed, although there are now some candidates for prediction of poststroke infections. Finally, as potential new candidates, we reviewed the pathophysiological actions of damage-associated molecular patterns as triggers of the neuroinflammatory cascade of stroke, and their possible use as biomarkers.

Global developmental delay and mental retardation--a pediatric perspective.

PubMed

Tirosh, Emanuel; Jaffe, Michael

2011-01-01

Pediatricians play a leading role in the detection, diagnosis, and management of children with global developmental delay (GDD) and mental retardation (MR). Assessment, investigation, and consultation with the family are the prime responsibility of the developmental pediatrician, in collaboration with a multidisciplinary team. The model used by the developmental pediatrician depends on the community health framework. Significant progress has been recently achieved in identifying underlying etiologies, using a variety of laboratory tests including neuroimaging and genetic and metabolic investigations. Although being used to achieve an acceptable yield, this progress in diagnostic investigations should be associated with proper weighing of the value of each test to the diagnostic process. Optimal utilization of this rapidly expanding knowledge can only be accomplished in the setting of in-depth clinical evaluation, including a thoughtful assessment of the child and family needs. In this article, the literature on the process of clinical evaluation and laboratory work-up of the child with GDD/MR is reviewed, with an emphasis on a multidisciplinary team approach to the child and family needs. An integrated model used by the developmental pediatrician that relates to the process of evaluation and management as well as the consequences of the diagnosis on the child, his/her family, and the community is suggested. Copyright © 2013 Wiley Periodicals, Inc.
Sustainable Development Goals and the Ongoing Process of Reducing Maternal Mortality.

PubMed

Callister, Lynn Clark; Edwards, Joan E

Innovative programs introduced in response to the Millennium Development Goals show promise to reduce the global rate of maternal mortality. The Sustainable Development Goals, introduced in 2015, were designed to build on this progress. In this article, we describe the global factors that contribute to maternal mortality rates, outcomes of the implementation of the Millennium Development Goals, and the new, related Sustainable Development Goals. Implications for clinical practice, health care systems, research, and health policy are provided. Copyright © 2017 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.
[Clinical competence evaluation in undergraduate gynecology and obstetrics].

PubMed

Larios Mendoza, Heriberto; Trejo Mejía, Juan Andrés; Gaviño Ambriz, Salvador; Cortés Gutiérrez, Ma Teresa

2002-11-01

Assess the clinical competence in Gynecology and obstetrics to the Internship students of the Faculty of Medicine, UNAM. The study design was descriptive, transverse type. We assessed 64 students, which had finished their gynecology field rotation with the objective structured clinical examination. The criteria to consider a competent performance level, was arbitrarily set up in 60%, both for individual problems and for the exam's global result. In 15 stations, the result was a 56.2 global average. The best performances were achieved in the following stations: take the pap smear (74.7), Pregnancy diagnostic (67.9), history of Gynecology and obstetrics (67.1), self examination of breast explanation (62.2) preclampsia (61.7) and cervicovaginitis (60). All the rest got a mark lower than 60. The results are lower than the ones obtained in written exams, because these cannot assess clinical skills. It could be observed that a student's performance in a clinical problem does not certainly predict his performance in other, so it seems to be determined more by the specific knowledge and the student's experience related to the case, than by a general problem-solving skill. The results show the advantages of this instrument to assess clinical skills, that justify its application in the formative process. This work evidences that its necessary to improve the acquisition of basic clinical skills trough systematic instructionals strategies and greater opportunities of learning.
Do the same factors predict outcome in schizophrenia and non-schizophrenia syndromes after first-episode psychosis? A two-year follow-up study.

PubMed

Peña, Javier; Segarra, Rafael; Ojeda, Natalia; García, Jon; Eguiluz, José I; Gutiérrez, Miguel

2012-06-01

The aim of this two-year longitudinal study was to identify the best baseline predictors of functional outcome in first-episode psychosis (FEP). We tested whether the same factors predict functional outcomes in two different subsamples of FEP patients: schizophrenia and non-schizophrenia syndrome groups. Ninety-five patients with FEP underwent a full clinical evaluation (i.e., PANSS, Mania, Depression and Insight). Functional outcome measurements included the WHO Disability Assessment Schedule (DAS-WHO), Global Assessment of Functioning (GAF) and Clinical Global Impression (CGI). Estimation of cognition was obtained by a neuropsychological battery which included attention, processing speed, language, memory and executive functioning. Greater severity of visuospatial functioning at baseline predicted poorer functional outcome as measured by the three functional scales (GAF, CGI and DAS-WHO) in the pooled FEP sample (explaining ut to the 12%, 9% and 10% of the variance, respectively). Negative symptoms also effectively contributed to predict GAF scores (8%). However, we obtained different predictive values after differentiating sample diagnoses. Processing speed significantly predicted most functional outcome measures in patients with schizophrenia, whereas visuospatial functioning was the only significant predictor of functional outcomes in the non-schizophrenia subgroup. Our results suggest that processing speed, visuospatial functioning and negative symptoms significantly (but differentially) predict outcomes in patients with FEP, depending on their clinical progression. For patients without a schizophrenia diagnosis, visuospatial functioning was the best predictor of functional outcome. The performance on processing speed seemed to be a key factor in more severe syndromes. However, only a small proportion of the variance could be explained by the model, so there must be many other factors that have to be considered. Copyright © 2012 Elsevier Ltd. All rights reserved.
Evolutionary History of the Global Emergence of the Escherichia coli Epidemic Clone ST131.

PubMed

Stoesser, Nicole; Sheppard, Anna E; Pankhurst, Louise; De Maio, Nicola; Moore, Catrin E; Sebra, Robert; Turner, Paul; Anson, Luke W; Kasarskis, Andrew; Batty, Elizabeth M; Kos, Veronica; Wilson, Daniel J; Phetsouvanh, Rattanaphone; Wyllie, David; Sokurenko, Evgeni; Manges, Amee R; Johnson, Timothy J; Price, Lance B; Peto, Timothy E A; Johnson, James R; Didelot, Xavier; Walker, A Sarah; Crook, Derrick W

2016-03-22

Escherichia colisequence type 131 (ST131) has emerged globally as the most predominant extraintestinal pathogenic lineage within this clinically important species, and its association with fluoroquinolone and extended-spectrum cephalosporin resistance impacts significantly on treatment. The evolutionary histories of this lineage, and of important antimicrobial resistance elements within it, remain unclearly defined. This study of the largest worldwide collection (n= 215) of sequenced ST131E. coliisolates to date demonstrates that the clonal expansion of two previously recognized antimicrobial-resistant clades, C1/H30R and C2/H30Rx, started around 25 years ago, consistent with the widespread introduction of fluoroquinolones and extended-spectrum cephalosporins in clinical medicine. These two clades appear to have emerged in the United States, with the expansion of the C2/H30Rx clade driven by the acquisition of ablaCTX-M-15-containing IncFII-like plasmid that has subsequently undergone extensive rearrangement. Several other evolutionary processes influencing the trajectory of this drug-resistant lineage are described, including sporadic acquisitions of CTX-M resistance plasmids and chromosomal integration ofblaCTX-Mwithin subclusters followed by vertical evolution. These processes are also occurring for another family of CTX-M gene variants more recently observed among ST131, theblaCTX-M-14/14-likegroup. The complexity of the evolutionary history of ST131 has important implications for antimicrobial resistance surveillance, epidemiological analysis, and control of emerging clinical lineages ofE. coli These data also highlight the global imperative to reduce specific antibiotic selection pressures and demonstrate the important and varied roles played by plasmids and other mobile genetic elements in the perpetuation of antimicrobial resistance within lineages. Escherichia coli, perennially a major bacterial pathogen, is becoming increasingly difficult to manage due to emerging resistance to all preferred antimicrobials. Resistance is concentrated within specificE. colilineages, such as sequence type 131 (ST131). Clarification of the genetic basis for clonally associated resistance is key to devising intervention strategies. We used high-resolution genomic analysis of a large global collection of ST131 isolates to define the evolutionary history of extended-spectrum beta-lactamase production in ST131. We documented diverse contributory genetic processes, including stable chromosomal integrations of resistance genes, persistence and evolution of mobile resistance elements within sublineages, and sporadic acquisition of different resistance elements. Both global distribution and regional segregation were evident. The diversity of resistance element acquisition and propagation within ST131 indicates a need for control and surveillance strategies that target both bacterial strains and mobile genetic elements. Copyright © 2016 Stoesser et al.
Local markets for global health technologies: lessons learned from advancing 6 new products.

PubMed

Matthias, Dipika Mathur; Taylor, Catharine H; Sen, Debjeet; Metzler, Mutsumi

2014-05-01

Key components to support local institutional and consumer markets are: supply chain, finance, clinical use, and consumer use. Key lessons learned: (1) Build supply and demand simultaneously. (2) Support a lead organization to drive the introduction process. (3) Plan for scale up from the start. (4) Profitability for the private sector is an absolute.
Organ donation and transplantation: Awareness and roles of healthcare professionals-A systematic literature review.

PubMed

Jawoniyi, Oluwafunmilayo; Gormley, Kevin; McGleenan, Emma; Noble, Helen Rose

2018-03-01

To examine the role of healthcare professionals in the organ donation and transplantation process. Globally, there remains a perennial disequilibrium between organ donation and organ transplantation. Several factors account for this disequilibrium; however, as healthcare professionals are not only strategically positioned as the primary intermediaries between organ donors and transplant recipients, but also professionally situated as the implementers of organ donation and transplantation processes, they are often blamed for the global organ shortage. Mixed-method systematic review using the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols 2015 checklist. Databases were searched including CINAHL, MEDLINE, Web of Science and EMBASE using the search terms "organ donation," "healthcare professionals," "awareness" and "roles" to retrieve relevant publications. Thirteen publications met the inclusion criteria. The global organ shortage is neither contingent upon unavailability of suitable organs nor exclusively dependent upon healthcare professionals. Instead, the existence of disequilibrium between organ donation and transplantation is necessitated by a web of factors. These include the following: healthcare professionals' attitudes towards, and experience of, the organ donation and transplantation process, underpinned by professional education, specialist clinical area and duration of professional practice; conflicts of interests; ethical dilemmas; altruistic values towards organ donation; and varied organ donation legislations in different legal jurisdictions. This review maintains that if this web of factors is to be adequately addressed by healthcare systems in different global and legal jurisdictions, there should be sufficient organs voluntarily donated to meet all transplantation needs. There is a suggestion that healthcare professionals partly account for the global shortage in organ donation, but there is a need to examine how healthcare professionals' roles, knowledge, awareness, skills and competencies might impact upon the organ donation and transplantation process. © 2017 John Wiley & Sons Ltd.
Diagnosing Autism in Individuals with Known Genetic Syndromes: Clinical Considerations and Implications for Intervention

PubMed Central

Hepburn, Susan L.; Moody, Eric J.

2015-01-01

Assessing symptoms of autism in persons with known genetic syndromes associated with intellectual and/or developmental disability is a complex clinical endeavor. We suggest that a developmental approach to evaluation is essential to reliably teasing apart global impairments from autism-specific symptomology. In this chapter, we discuss our assumptions about autism spectrum disorders, the process of conducting a family-focused, comprehensive evaluation with behaviorally complex children and some implications for intervention in persons with co-occurring autism and known genetic syndromes. PMID:26269783
Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada.

PubMed

Kluetz, Paul G; O'Connor, Daniel J; Soltys, Katherine

2018-05-01

The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into the clinical decision-making process is of increasing interest to the international regulatory and health policy community. Disease and treatment-related symptoms and their effect on patient function and health-related quality of life are important outcomes to consider. The identification of methods to scientifically assess, analyse, interpret, and present these clinical outcomes requires sustained international collaboration by multiple stakeholders including patients, clinicians, scientists, and policy makers. Several data sources can be considered to capture the patient experience, including patient-reported outcome (PRO) measures, performance measures, wearable devices, and biosensors, as well as the careful collection and analysis of clinical events and supportive care medications. In this Policy Review, we focus on PRO measures and present the perspectives of three international regulatory scientists to identify areas of common ground regarding opportunities to incorporate rigorous PRO data into the regulatory decision-making process. Copyright © 2018 Elsevier Ltd. All rights reserved.
Ethical considerations for clinical photography in the global South.

PubMed

Macintosh, Tracy

2006-05-01

Clinical photography is an important tool for teaching practitioners and field workers about the clinical manifestations of famine and undernutrition, particularly with respect to the Global South. Current international guidelines for clinical photography are not consistently applied or enforced, which has led to violations of privacy and rights, particularly for patients and victims of disaster in the Global South. Combining existing clinical photography guidelines from the North with ongoing clinical ethics debates in the South, this paper explores approaches to establishing photography guidelines throughout the world that will be sensitive to the privacy and dignities of all patients and victims of emergencies.
Junior doctors' extended work hours and the effects on their performance: the Irish case.

PubMed

Flinn, Fiona; Armstrong, Claire

2011-04-01

To explore the relationship between junior doctors' long working hours and their performance in a variety of cognitive and clinical decision-making tests. Also, to consider the implications of performance decrements in such tests for healthcare quality. A within-subject design was used to eliminate variation related to individual differences. Each participant was tested twice, once post call and once rested. At each session, participants were tested on cognitive functioning and clinical decision-making. The study was based on six acute Irish hospitals during 2008. Thirty junior hospital doctors, ages ranged from 23 to 30 years; of them, 17 of the participants were female and 13 were male. Measures Cognitive functioning was measured by the MindStreams Global Assessment Battery (NeuroTrax Corp., NY, USA). This is a set of computerized tests, designed for use in medical settings, that assesses performance in memory, executive function, visual spatial perception, verbal function, attention, information processing speed and motor skills. Clinical decision-making was tested using Key Features Problems. Each Key Features Problem consists of a case scenario and then three to four questions about this scenario. In an effort to make it more realistic, the speed with which participants completed the three problems was also recorded. Participants' global cognitive scores, attention, information processing speed and motor skills were significantly worse post call than when rested. They also took longer to complete clinical decision-making questions in the post-call condition and obtained lower scores than when rested. There are significant negative changes in doctors' cognitive functioning and clinical decision-making performance that appear to be attributable to long working hours. This therefore raises the important question of whether working long hours decreases healthcare quality and compromises patient safety.
Global health training and international clinical rotations during residency: current status, needs, and opportunities.

PubMed

Drain, Paul K; Holmes, King K; Skeff, Kelley M; Hall, Thomas L; Gardner, Pierce

2009-03-01

Increasing international travel and migration have contributed to globalization of diseases. Physicians today must understand the global burden and epidemiology of diseases, the disparities and inequities in global health systems, and the importance of cross-cultural sensitivity. To meet these needs, resident physicians across all specialties have expressed growing interest in global health training and international clinical rotations. More residents are acquiring international experience, despite inadequate guidance and support from most accreditation organizations and residency programs. Surveys of global health training, including international clinical rotations, highlight the benefits of global health training as well as the need for a more coordinated approach. In particular, international rotations broaden a resident's medical knowledge, reinforce physical examination skills, and encourage practicing medicine among underserved and multicultural populations. As residents recognize these personal and professional benefits, a strong majority of them seek to gain international clinical experience. In conclusion, with feasible and appropriate administrative steps, all residents can receive global health training and be afforded the accreditation and programmatic support to participate in safe international rotations. The next steps should address accreditation for international rotations and allowance for training away from continuity clinics by residency accreditation bodies, and stipend and travel support for six or more weeks of call-free elective time from residency programs.
Recruiting post-doctoral fellows into global health research: selecting NIH Fogarty International Clinical Research Fellows.

PubMed

Heimburger, Douglas C; Warner, Tokesha L; Carothers, Catherine Lem; Blevins, Meridith; Thomas, Yolanda; Gardner, Pierce; Primack, Aron; Vermund, Sten H

2014-08-01

From 2008 to 2012, the National Institutes of Health (NIH) Fogarty International Clinical Research Fellows Program (FICRF) provided 1-year mentored research training at low- and middle-income country sites for American and international post-doctoral health professionals. We examined the FICRF applicant pool, proposed research topics, selection process, and characteristics of enrollees to assess trends in global health research interest and factors associated with applicant competitiveness. The majority (58%) of 67 US and 57 international Fellows were women, and 83% of Fellows had medical degrees. Most applicants were in clinical fellowships (41%) or residencies (24%). More applicants proposing infectious disease projects were supported (59%) than applicants proposing non-communicable disease (NCD) projects (41%), although projects that combined both topic areas were most successful (69%). The numbers of applicants proposing research on NCDs and the numbers of these applicants awarded fellowships rose dramatically over time. Funding provided to the FICRF varied significantly among NIH Institutes and Centers and was strongly associated with the research topics awarded. © The American Society of Tropical Medicine and Hygiene.
Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.

PubMed

Takahashi, K; Sengoku, S; Kimura, H

2011-02-01

A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.
Non-adoption of Option B+ for prevention of mother-to-child transmission of HIV in Nigeria: A look at the policymaking process.

PubMed

Olakunde, Babayemi Oluwaseun; Ndukwe, Chinwendu Daniel

2017-02-01

In 2012, the World Health Organization recommended 'Option B+' (lifelong antiretroviral treatment for HIV-infected pregnant women regardless of their CD4 count or WHO clinical stage) for prevention of mother-to-child transmission of HIV-based on its operational and clinical advantages. By 2015, 21 out of the 22 Global Plan priority countries had adopted the Option B+ approach. Despite its huge HIV burden, Nigeria is the only country yet to adopt Option B+. We analyse the policymaking process on Option B+ in Nigeria from 2012-2015, highlighting how factors related to the content (uncertainty about Option B+, lack of local evidence), actors (interest and power) and context (low domestic funding and poor retention in care) affected the policymaking process and present the implications of this decision for improving HIV response in Nigeria.
Protein mass spectra data analysis for clinical biomarker discovery: a global review.

PubMed

Roy, Pascal; Truntzer, Caroline; Maucort-Boulch, Delphine; Jouve, Thomas; Molinari, Nicolas

2011-03-01

The identification of new diagnostic or prognostic biomarkers is one of the main aims of clinical cancer research. In recent years there has been a growing interest in using high throughput technologies for the detection of such biomarkers. In particular, mass spectrometry appears as an exciting tool with great potential. However, to extract any benefit from the massive potential of clinical proteomic studies, appropriate methods, improvement and validation are required. To better understand the key statistical points involved with such studies, this review presents the main data analysis steps of protein mass spectra data analysis, from the pre-processing of the data to the identification and validation of biomarkers.
Is inefficient cognitive processing in anorexia nervosa a familial trait? A neuropsychological pilot study of mothers of offspring with a diagnosis of anorexia nervosa.

PubMed

Lang, Katie; Treasure, Janet; Tchanturia, Kate

2016-06-01

Inefficient set shifting and poor global processing are thought to be possible traits in anorexia nervosa (AN). This study aimed to investigate the neuropsychological processing style of unaffected mothers of offspring with AN (unaffected AN mothers). The performance of 21 unaffected AN mothers were compared to 20 mothers of healthy control offspring on neuropsychological measures of set shifting (Wisconsin Card Sorting Test, WCST) and central coherence (Fragmented Pictures Task, FPT, and Rey Osterrieth Complex Figures Task, ROCFT). Associations between neuropsychological performance and clinical measures were examined in the unaffected AN mothers group. There were significant differences in perseverative errors on the WCST (P≤0.01), with the unaffected mothers displaying a more inflexible thinking style compared to the control group. There were also significant differences on the FPT (P ≤ 0.01) and the ROCFT (P ≤ 0.01), whereby unaffected AN mothers showed lower levels of global processing. The results of this study support the idea of the familial nature of cognitive styles in AN. The implications of these findings are discussed.
India's growing clinical research sector: opportunity for global companies.

PubMed

Varawalla, Nermeen

2007-06-01

Backed by a compelling foundation of essential requirements necessary for effective clinical trial conduct, and aided by initiatives that address concerns of data quality, regulatory timelines and IP protection, the clinical development sector in India has experienced annual revenue growth rates of 25% in the past two to three years, and is poised to participate substantially in global drug development. As both clinical trial sponsors and CROs increase their research capabilities in India, the clinical development sector is facing challenges with staff resourcing and facilities. Existing initiatives in the clinical sector must continue, and further investment must be made by stakeholders to overcome the current limitations in sector growth. Furthermore, global organizations seeking to derive long-term sustainable revenue growth and competitive advantage in the global marketplace from their business units in India must establish an appropriate organizational culture and an effective intra-organizational and industry interface for their operations.
Clinical knowledge governance: the international perspective.

PubMed

Garde, Sebastian

2013-01-01

As a basis for semantic interoperability, ideally, a Clinical Knowledge Resource for a clinical concept should be defined formally and defined once in a way that all clinical professions and all countries can agree on. Clinical Knowledge Governance is required to create high-quality, reusable Clinical Knowledge Resources and achieve this aim. Traditionally, this is a time-consuming and cumbersome process, relying heavily on face-to-face meetings and being able to get sufficient input from clinicians. However, in a national or even international space, it is required to streamline the processes involved in creating Clinical Knowledge Resources. For this, a Web 2.0 tool that supports online collaboration of clinicians during their creation and publishing of Clinical Knowledge Resources has been developed. This tool is named the Clinical Knowledge Manager (CKM) and supports the development, review and publication of Clinical Knowledge Resources. Also, post-publication activities such as adding terminology bindings, translating the Clinical Knowledge Resource into another language and republishing it are supported. The acceptance of Clinical Knowledge Resources depends on their quality and being able to determine their quality, for example it is important to know that a broad umber of reviewers from various clinical disciplines have been involved in the development of the Clinical Knowledge Resource. We are still far from realizing the vision of a global repository of a great number of reusable, high-quality Clinical Knowledge Resources, which can provide the basis for broad semantic interoperability between systems. However progress towards this aim is being made around the world.
Impaired visual recognition of biological motion in schizophrenia.

PubMed

Kim, Jejoong; Doop, Mikisha L; Blake, Randolph; Park, Sohee

2005-09-15

Motion perception deficits have been suggested to be an important feature of schizophrenia but the behavioral consequences of such deficits are unknown. Biological motion refers to the movements generated by living beings. The human visual system rapidly and effortlessly detects and extracts socially relevant information from biological motion. A deficit in biological motion perception may have significant consequences for detecting and interpreting social information. Schizophrenia patients and matched healthy controls were tested on two visual tasks: recognition of human activity portrayed in point-light animations (biological motion task) and a perceptual control task involving detection of a grouped figure against the background noise (global-form task). Both tasks required detection of a global form against background noise but only the biological motion task required the extraction of motion-related information. Schizophrenia patients performed as well as the controls in the global-form task, but were significantly impaired on the biological motion task. In addition, deficits in biological motion perception correlated with impaired social functioning as measured by the Zigler social competence scale [Zigler, E., Levine, J. (1981). Premorbid competence in schizophrenia: what is being measured? Journal of Consulting and Clinical Psychology, 49, 96-105.]. The deficit in biological motion processing, which may be related to the previously documented deficit in global motion processing, could contribute to abnormal social functioning in schizophrenia.

Adjunctive minocycline treatment for major depressive disorder: A proof of concept trial.

PubMed

Dean, Olivia M; Kanchanatawan, Buranee; Ashton, Melanie; Mohebbi, Mohammadreza; Ng, Chee Hong; Maes, Michael; Berk, Lesley; Sughondhabirom, Atapol; Tangwongchai, Sookjaroen; Singh, Ajeet B; McKenzie, Helen; Smith, Deidre J; Malhi, Gin S; Dowling, Nathan; Berk, Michael

2017-08-01

Conventional antidepressant treatments result in symptom remission in 30% of those treated for major depressive disorder, raising the need for effective adjunctive therapies. Inflammation has an established role in the pathophysiology of major depressive disorder, and minocycline has been shown to modify the immune-inflammatory processes and also reduce oxidative stress and promote neuronal growth. This double-blind, randomised, placebo-controlled trial examined adjunctive minocycline (200 mg/day, in addition to treatment as usual) for major depressive disorder. This double-blind, randomised, placebo-controlled trial investigated 200 mg/day adjunctive minocycline (in addition to treatment as usual) for major depressive disorder. A total of 71 adults with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition) were randomised to this 12-week trial. Outcome measures included the Montgomery-Asberg Depression Rating Scale (primary outcome), Clinical Global Impression-Improvement and Clinical Global Impression-Severity, Hamilton Anxiety Rating Scale, Quality of Life Enjoyment and Satisfaction Questionnaire, Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool. The study was registered on the Australian and New Zealand Clinical Trials Register: www.anzctr.org.au , #ACTRN12612000283875. Based on mixed-methods repeated measures analysis of variance at week 12, there was no significant difference in Montgomery-Asberg Depression Rating Scale scores between groups. However, there were significant differences, favouring the minocycline group at week 12 for Clinical Global Impression-Improvement score - effect size (95% confidence interval) = -0.62 [-1.8, -0.3], p = 0.02; Quality of Life Enjoyment and Satisfaction Questionnaire score - effect size (confidence interval) = -0.12 [0.0, 0.2], p < 0.001; and Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool score - 0.79 [-4.5, -1.4], p < 0.001. These effects remained at follow-up (week 16), and Patient Global Impression also became significant, effect size (confidence interval) = 0.57 [-1.7, -0.4], p = 0.017. While the primary outcome was not significant, the improvements in other comprehensive clinical measures suggest that minocycline may be a useful adjunct to improve global experience, functioning and quality of life in people with major depressive disorder. Further studies are warranted to confirm the potential of this accessible agent to optimise treatment outcomes.
Global interrupt and barrier networks

DOEpatents

Blumrich, Matthias A.; Chen, Dong; Coteus, Paul W.; Gara, Alan G.; Giampapa, Mark E; Heidelberger, Philip; Kopcsay, Gerard V.; Steinmacher-Burow, Burkhard D.; Takken, Todd E.

2008-10-28

A system and method for generating global asynchronous signals in a computing structure. Particularly, a global interrupt and barrier network is implemented that implements logic for generating global interrupt and barrier signals for controlling global asynchronous operations performed by processing elements at selected processing nodes of a computing structure in accordance with a processing algorithm; and includes the physical interconnecting of the processing nodes for communicating the global interrupt and barrier signals to the elements via low-latency paths. The global asynchronous signals respectively initiate interrupt and barrier operations at the processing nodes at times selected for optimizing performance of the processing algorithms. In one embodiment, the global interrupt and barrier network is implemented in a scalable, massively parallel supercomputing device structure comprising a plurality of processing nodes interconnected by multiple independent networks, with each node including one or more processing elements for performing computation or communication activity as required when performing parallel algorithm operations. One multiple independent network includes a global tree network for enabling high-speed global tree communications among global tree network nodes or sub-trees thereof. The global interrupt and barrier network may operate in parallel with the global tree network for providing global asynchronous sideband signals.
Evidence of Reduced Global Processing in Autism Spectrum Disorder.

PubMed

Booth, Rhonda D L; Happé, Francesca G E

2018-04-01

Frith's original notion of 'weak central coherence' suggested that increased local processing in autism spectrum disorder (ASD) resulted from reduced global processing. More recent accounts have emphasised superior local perception and suggested intact global integration. However, tasks often place local and global processing in direct trade-off, making it difficult to determine whether group differences reflect reduced global processing, increased local processing, or both. We present two measures of global integration in which poor performance could not reflect increased local processing. ASD participants were slower to identify fragmented figures and less sensitive to global geometric impossibility than IQ-matched controls. These findings suggest that reduced global integration comprises one important facet of weak central coherence in ASD.
Validity and reliability problems with patient global as a component of the ACR/EULAR remission criteria as used in clinical practice.

PubMed

Masri, Karim R; Shaver, Timothy S; Shahouri, Shadi H; Wang, Shirley; Anderson, James D; Busch, Ruth E; Michaud, Kaleb; Mikuls, Ted R; Caplan, Liron; Wolfe, Frederick

2012-06-01

To investigate what factors influence patient global health assessment (PtGlobal), and how those factors and the reliability of PtGlobal affect the rate, reliability, and validity of recently published American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) rheumatoid arthritis (RA) remission criteria when used in clinical practice. We examined consecutive patients with RA in clinical practice and identified 77 who met ACR/EULAR joint criteria for remission (≤ 1 swollen joint and ≤ 1 tender joint). We evaluated factors associated with a PtGlobal > 1, because a PtGlobal ≤ 1 defined ACR/EULAR remission in this group of patients who had already met ACR/EULAR joint criteria. Of the 77 patients examined, only 17 (22.1%) had PtGlobal ≤ 1 and thus fully satisfied ACR/EULAR criteria. A large proportion of patients not in remission by ACR/EULAR criteria had high PtGlobal related to noninflammatory issues, including low back pain, fatigue, and functional limitations, and a number of patients clustered in the range of PtGlobal > 1 and ≤ 2. However, the minimal detectable difference for PtGlobal was 2.3. In addition, compared with a PtGlobal severity score, a PtGlobal activity score was 3.3% less likely to be abnormal (> 1). Noninflammatory factors contribute to the level of PtGlobal and result in the exclusion of many patients who would otherwise be in "true" remission according to the ACR/EULAR definition. Reliability problems associated with PtGlobal can also result in misclassification, and may explain the observation of low longterm remission rates in RA. As currently constituted, the use of the ACR/EULAR remission criteria in clinical practice appears to be problematic.
Proposal for the development of biologics in pediatric rheumatology.

PubMed

Mori, Masaaki; Nakagawa, Masao; Tsuchida, Nao; Kawada, Kou; Sato, Junko; Sakiyama, Michiyo; Hirano, Shinya; Sato, Katsuaki; Nakamura, Hidefumi

2018-02-01

In order to assess the development, approval and early introduction into clinical practice of biologics in the pediatric field, we herein describe the current status of the development to approval of biologics as anti-rheumatic agents for children in Japan, discuss the present problems and provide a proposal for the future. It has become apparent that the duration of the review period required for the preparation of clinical trials and Pharmaceuticals and Medical Devices Agency approval is clearly reduced compared with the past. Thus, it was speculated that a rate-limiting step in the process from development to approval was the duration of clinical trials from start to end. Hence, we focused on the following key words with regard to promotion of the development of biologics and their early practical use: "registry", "centralization", and "global cooperation", all of which are related to the reduction of duration of a clinical trial. In conclusion, to reduce the duration of a clinical trial, it is essential to complete a world-scale registry system by developing the registry system established by the Pediatric Rheumatology Association of Japan. The next step is then to carefully plan to participate in the international network using the world-scale registry system, and develop global cooperative trials in which we can ensure a sufficient number of entries from Japan. © 2017 Japan Pediatric Society.
Prediction of vocational participation and global role functioning in help-seeking young adults, from neurocognitive, demographic and clinical variables.

PubMed

Cairns, Alice J; Kavanagh, David J; Dark, Frances; McPhail, Steven M

2017-10-15

The purpose of this study was to investigate neurocognitive, demographic and clinical correlates of vocational participation among a sample of young help-seeking adults. Young people (18-25 years) accessing an early intervention youth health service participated. The Global Functioning: Role scale and level of vocational participation, participant characteristics (age, gender, socioeconomic background and family history of serious mental illness), distress, psychotic-like experiences, substance use, and mental health diagnoses were recorded. The Cambridge Neuropsychological Testing Automated Battery was used to assess sustained attention, visual memory and executive function. Of the 107 participants, 33 (31%) were not working or studying and 52 (49%) had a diagnosis of affective disorder. Impairments in neurocognitive tests were evidenced in attention shift, sustained attention target sensitivity, impulsivity and spatial working memory errors. Univariate analyses indicated that information processing and target impulsivity were associated with both vocational participation and global functioning, and that spatial working memory strategy was also associated with vocational participation. After controlling for significant demographic and clinical predictors, strategy formation remained a significant correlate of vocational participation (coefficient (95%CI) = -0.08 (-0.17, -0.01)), but no neurocognitive measures remained significant in the multivariate prediction of global functioning. Neurocognitive outcomes were assessed at a single time point, factors such as fluctuations in motivation could impact on test results. Interventions targeting work and education participation should consider the capacity of vulnerable young people to develop appropriate plans for role success and provide support accordingly. The study also emphasised the importance of high school completion and avoidance of cannabis use, especially in males. Copyright © 2017 Elsevier B.V. All rights reserved.
Biopharmaceutical innovation and industrial developments in South Korea, Singapore and Taiwan.

PubMed

Hsieh, Chee-Ruey; Löfgren, Hans

2009-05-01

South Korea, Singapore and Taiwan are well known as export-oriented developmental states which for decades employed industrial policy to target particular industries for government support. In the past fifteen years, these three countries all identified the biopharmaceutical industry as a strategic sector. This article explores, through economic analysis, the rationale for this decision and the strategies chosen for linking into the global bio-economy with the objective of catching up in biopharmaceuticals. The paper identifies three comparative advantages enjoyed by these countries in the biopharma sector: (1) public investments in basic research; (2) private investments in phase 1 clinical trials; and (3) a potentially significant contract research industry managing latter-stage clinical trials. Governments employ a range of industrial policies, consistent with these comparative advantages, to promote the biopharmaceutical industry, including public investment in biomedical hubs, research funding and research and development (R&D) tax credits. We argue that the most important feature of the biopharmaceutical industry in these countries is the dominant role of the public sector. That these countries have made progress in innovative capabilities is illustrated by input measures such as R&D expenditure as share of gross domestic product, number of patents granted and clinical trials, and volume of foreign direct investment. In contrast, output indicators such as approval of new chemical entities suggest that the process of catching up has only just commenced. Pharmaceutical innovation is at the stage of mainly generating inputs to integrated processes controlled by the globally incumbent firms.
Optimization of the decision-making process for the selection of therapeutics to undergo clinical testing for spinal cord injury in the North American Clinical Trials Network.

PubMed

Guest, James; Harrop, James S; Aarabi, Bizhan; Grossman, Robert G; Fawcett, James W; Fehlings, Michael G; Tator, Charles H

2012-09-01

The North American Clinical Trials Network (NACTN) includes 9 clinical centers funded by the US Department of Defense and the Christopher Reeve Paralysis Foundation. Its purpose is to accelerate clinical testing of promising therapeutics in spinal cord injury (SCI) through the development of a robust interactive infrastructure. This structure includes key committees that serve to provide longitudinal guidance to the Network. These committees include the Executive, Data Management, and Neurological Outcome Assessments Committees, and the Therapeutic Selection Committee (TSC), which is the subject of this manuscript. The NACTN brings unique elements to the SCI field. The Network's stability is not restricted to a single clinical trial. Network members have diverse expertise and include experts in clinical care, clinical trial design and methodology, pharmacology, preclinical and clinical research, and advanced rehabilitation techniques. Frequent systematic communication is assigned a high value, as is democratic process, fairness and efficiency of decision making, and resource allocation. This article focuses on how decision making occurs within the TSC to rank alternative therapeutics according to 2 main variables: quality of the preclinical data set, and fit with the Network's aims and capabilities. This selection process is important because if the Network's resources are committed to a therapeutic, alternatives cannot be pursued. A proposed methodology includes a multicriteria decision analysis that uses a Multi-Attribute Global Inference of Quality matrix to quantify the process. To rank therapeutics, the TSC uses a series of consensus steps designed to reduce individual and group bias and limit subjectivity. Given the difficulties encountered by industry in completing clinical trials in SCI, stable collaborative not-for-profit consortia, such as the NACTN, may be essential to clinical progress in SCI. The evolution of the NACTN also offers substantial opportunity to refine decision making and group dynamics. Making the best possible decisions concerning therapeutics selection for trial testing is a cornerstone of the Network's function.
ARABIC TRANSLATION AND ADAPTATION OF THE HOSPITAL CONSUMER ASSESSMENT OF HEALTHCARE PROVIDERS AND SYSTEMS (HCAHPS) PATIENT SATISFACTION SURVEY INSTRUMENT.

PubMed

Dockins, James; Abuzahrieh, Ramzi; Stack, Martin

2015-01-01

To translate and adapt an effective, validated, benchmarked, and widely used patient satisfaction measurement tool for use with an Arabic-speaking population. Translation of survey's items, survey administration process development, evaluation of reliability, and international benchmarking Three hundred-bed tertiary care hospital in Jeddah, Saudi Arabia. 645 patients discharged during 2011 from the hospital's inpatient care units. INTERVENTIONS; The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) instrument was translated into Arabic, a randomized weekly sample of patients was selected, and the survey was administered via telephone during 2011 to patients or their relatives. Scores were compiled for each of the HCAHPS questions and then for each of the six HCAHPS clinical composites, two non-clinical items, and two global items. Clinical composite scores, as well as the two non-clinical and two global items were analyzed for the 645 respondents. Clinical composites were analyzed using Spearman's correlation coefficient and Cronbach's alpha to demonstrate acceptable internal consistency for these items and scales demonstrated acceptable internal consistency for the clinical composites. (Spearman's correlation coefficient = 0.327 - 0.750, P < 0.01; Cronbach's alpha = 0.516 - 0.851) All ten HCAHPS measures were compared quarterly to US national averages with results that closely paralleled the US benchmarks. . The Arabic translation and adaptation of the HCAHPS is a valid, reliable, and feasible tool for evaluation and benchmarking of inpatient satisfaction in Arabic speaking populations.
A novel approach to assess clinical competence of postgraduate year 1 surgery residents

PubMed Central

Qi, Xin; Ding, Lian; Zhai, Wei; Li, Qiang; Li, Yan; Li, Haichao; Wen, Bing

2017-01-01

ABSTRACT Background: An increased demand for accountability and transparency in medicine have initiated a shift toward a more objective and standardized approach for postgraduate medical training. Objective: To develop and evaluate an objective method to assess clinical competence of postgraduate year 1 surgery residents. Design: Thirty-one postgraduate year 1 surgery residents, who had been trained in the Surgical School of Peking University First Hospital for one year, participated in an objective structured clinical examination as a final assessment of their clinical competence. A test station of irregular wound repair (debridement and suture) was specially designed to test the residents’ surgical integrative competence in a complex-trauma treatment procedure. A modified global rating scale, in combination with wound area measurement, was applied to evaluate residents’ surgical performance. The validity of the subjective global rating scale was evaluated by the objective measurement results from the software. Results: The global rating scale score had no obvious correlation with the area of the removed tissue and the residual wound area after the suture. There was significant difference in the debridement time and the residual wound area between 0–3 and >3 total stitches. There were significant differences in the area of the removed tissue between 0 and 1–2 grey stitches and 0 and 3–4 grey stitches, and in the residual wound area after suture between 0 and 3–4 grey stitches and 1–2 and 3–4 grey stitches. Conclusions: An irregular wound repair procedure could be an effective method to assess the integrative competence of surgery residents. The training for surgical thinking in the early stage of junior residents needs to be strengthened. The entire measurement process was more complex and time-consuming than expected. The possibility of measurement by simply counting the numbers of the key spots might be explored in the future. Abbreviations: ACS/APDS American College of Surgeons/Association of Program Directors in Surgery; GRS Global rating scale; LSD-T Least significant difference-test; OSATS Objective structured assessment of technical skills; OSCE Objective structured clinical examination; PBT Proficiency based training; PGY1 Postgraduate Year 1 PMID:28670976
Towards a global cancer knowledge network: dissecting the current international cancer genomic sequencing landscape.

PubMed

Vis, D J; Lewin, J; Liao, R G; Mao, M; Andre, F; Ward, R L; Calvo, F; Teh, B T; Camargo, A A; Knoppers, B M; Sawyers, C L; Wessels, L F A; Lawler, M; Siu, L L; Voest, E

2017-05-01

While next generation sequencing has enhanced our understanding of the biological basis of malignancy, current knowledge on global practices for sequencing cancer samples is limited. To address this deficiency, we developed a survey to provide a snapshot of current sequencing activities globally, identify barriers to data sharing and use this information to develop sustainable solutions for the cancer research community. A multi-item survey was conducted assessing demographics, clinical data collection, genomic platforms, privacy/ethics concerns, funding sources and data sharing barriers for sequencing initiatives globally. Additionally, respondents were asked as to provide the primary intent of their initiative (clinical diagnostic, research or combination). Of 107 initiatives invited to participate, 59 responded (response rate = 55%). Whole exome sequencing (P = 0.03) and whole genome sequencing (P = 0.01) were utilized less frequently in clinical diagnostic than in research initiatives. Procedures to identify cancer-specific variants were heterogeneous, with bioinformatics pipelines employing different mutation calling/variant annotation algorithms. Measurement of treatment efficacy varied amongst initiatives, with time on treatment (57%) and RECIST (53%) being the most common; however, other parameters were also employed. Whilst 72% of initiatives indicated data sharing, its scope varied, with a number of restrictions in place (e.g. transfer of raw data). The largest perceived barriers to data harmonization were the lack of financial support (P < 0.01) and bioinformatics concerns (e.g. lack of interoperability) (P = 0.02). Capturing clinical data was more likely to be perceived as a barrier to data sharing by larger initiatives than by smaller initiatives (P = 0.01). These results identify the main barriers, as perceived by the cancer sequencing community, to effective sharing of cancer genomic and clinical data. They highlight the need for greater harmonization of technical, ethical and data capture processes in cancer sample sequencing worldwide, in order to support effective and responsible data sharing for the benefit of patients. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
Validity of faculty and resident global assessment of medical students' clinical knowledge during their pediatrics clerkship.

PubMed

Dudas, Robert A; Colbert, Jorie M; Goldstein, Seth; Barone, Michael A

2012-01-01

Medical knowledge is one of six core competencies in medicine. Medical student assessments should be valid and reliable. We assessed the relationship between faculty and resident global assessment of pediatric medical student knowledge and performance on a standardized test in medical knowledge. Retrospective cross-sectional study of medical students on a pediatric clerkship in academic year 2008-2009 at one academic health center. Faculty and residents rated students' clinical knowledge on a 5-point Likert scale. The inter-rater reliability of clinical knowledge ratings was assessed by calculating the intra-class correlation coefficient (ICC) for residents' ratings, faculty ratings, and both rating types combined. Convergent validity between clinical knowledge ratings and scores on the National Board of Medical Examiners (NBME) clinical subject examination in pediatrics was assessed with Pearson product moment correlation correction and the coefficient of the determination. There was moderate agreement for global clinical knowledge ratings by faculty and moderate agreement for ratings by residents. The agreement was also moderate when faculty and resident ratings were combined. Global ratings of clinical knowledge had high convergent validity with pediatric examination scores when students were rated by both residents and faculty. Our findings provide evidence for convergent validity of global assessment of medical students' clinical knowledge with NBME subject examination scores in pediatrics. Copyright Â© 2012 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.
Understanding Perspectives of African American Medicaid-Insured Women on the Process of Perinatal Care: An Opportunity for Systems Improvement.

PubMed

Roman, Lee Anne; Raffo, Jennifer E; Dertz, Katherine; Agee, Bonita; Evans, Denise; Penninga, Katherine; Pierce, Tiffany; Cunningham, Belinda; VanderMeulen, Peggy

2017-12-01

Objectives To address disparities in adverse birth outcomes, communities are challenged to improve the quality of health services and foster systems integration. The purpose of this study was to explore the perspectives of Medicaid-insured women about their experiences of perinatal care (PNC) across a continuum of clinical and community-based services. Methods Three focus groups (N = 21) were conducted and thematic analysis methods were used to identify basic and global themes about experiences of care. Women were recruited through a local Federal Healthy Start (HS) program in Michigan that targets services to African American women. Results Four basic themes were identified: (1) Pursuit of PNC; (2) Experiences of traditional PNC; (3) Enhanced prenatal and postnatal care; and (4) Women's health: A missed opportunity. Two global themes were also identified: (1) Communication with providers, and (2) Perceived socio-economic and racial bias. Many women experienced difficulties engaging in early care, getting more help, and understanding and communicating with their providers, with some reporting socio-economic and racial bias in care. Delays in PNC limited early access to HS and enhanced prenatal care (EPC) programs with little evidence of supportive transitions to primary care. Notably, women's narratives revealed few connections among clinical and community-based services. Conclusions The process of participating in PNC and community-based programs is challenging for women, especially for those with multiple health problems and living in difficult life circumstances. PNC, HS and other EPC programs could partner to streamline processes, improve the content and process of care, and enhance engagement in services.
KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors.

PubMed

Lentine, Krista L; Kasiske, Bertram L; Levey, Andrew S; Adams, Patricia L; Alberú, Josefina; Bakr, Mohamed A; Gallon, Lorenzo; Garvey, Catherine A; Guleria, Sandeep; Li, Philip Kam-Tao; Segev, Dorry L; Taler, Sandra J; Tanabe, Kazunari; Wright, Linda; Zeier, Martin G; Cheung, Michael; Garg, Amit X

2017-08-01

The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant studies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive approach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses were undertaken to produce a "proof-in-concept" risk-prediction model for kidney failure to support a framework for quantitative risk assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the simultaneous consideration of each candidate's profile of demographic and health characteristics. The processes and framework for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk prediction and novel approaches to estimating donation-attributable risks, are also provided.In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017;101(Suppl 8S):S1-S109.
MITK global tractography

NASA Astrophysics Data System (ADS)

Neher, Peter F.; Stieltjes, Bram; Reisert, Marco; Reicht, Ignaz; Meinzer, Hans-Peter; Fritzsche, Klaus H.

2012-02-01

Fiber tracking algorithms yield valuable information for neurosurgery as well as automated diagnostic approaches. However, they have not yet arrived in the daily clinical practice. In this paper we present an open source integration of the global tractography algorithm proposed by Reisert et.al.1 into the open source Medical Imaging Interaction Toolkit (MITK) developed and maintained by the Division of Medical and Biological Informatics at the German Cancer Research Center (DKFZ). The integration of this algorithm into a standardized and open development environment like MITK enriches accessibility of tractography algorithms for the science community and is an important step towards bringing neuronal tractography closer to a clinical application. The MITK diffusion imaging application, downloadable from www.mitk.org, combines all the steps necessary for a successful tractography: preprocessing, reconstruction of the images, the actual tracking, live monitoring of intermediate results, postprocessing and visualization of the final tracking results. This paper presents typical tracking results and demonstrates the steps for pre- and post-processing of the images.
Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

PubMed

Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

2014-01-01

International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.
Emerging proteomics biomarkers and prostate cancer burden in Africa

PubMed Central

Adeola, Henry A.; Blackburn, Jonathan M.; Rebbeck, Timothy R.; Zerbini, Luiz F.

2017-01-01

Various biomarkers have emerged via high throughput omics-based approaches for use in diagnosis, treatment, and monitoring of prostate cancer. Many of these have yet to be demonstrated as having value in routine clinical practice. Moreover, there is a dearth of information on validation of these emerging prostate biomarkers within African cohorts, despite the huge burden and aggressiveness of prostate cancer in men of African descent. This review focusses of the global landmark achievements in prostate cancer proteomics biomarker discovery and the potential for clinical implementation of these biomarkers in Africa. Biomarker validation processes at the preclinical, translational and clinical research level are discussed here, as are the challenges and prospects for the evaluation and use of novel proteomic prostate cancer biomarkers. PMID:28388542
Emerging proteomics biomarkers and prostate cancer burden in Africa.

PubMed

Adeola, Henry A; Blackburn, Jonathan M; Rebbeck, Timothy R; Zerbini, Luiz F

2017-06-06

Various biomarkers have emerged via high throughput omics-based approaches for use in diagnosis, treatment, and monitoring of prostate cancer. Many of these have yet to be demonstrated as having value in routine clinical practice. Moreover, there is a dearth of information on validation of these emerging prostate biomarkers within African cohorts, despite the huge burden and aggressiveness of prostate cancer in men of African descent. This review focusses of the global landmark achievements in prostate cancer proteomics biomarker discovery and the potential for clinical implementation of these biomarkers in Africa. Biomarker validation processes at the preclinical, translational and clinical research level are discussed here, as are the challenges and prospects for the evaluation and use of novel proteomic prostate cancer biomarkers.
Global issues in drug development for Alzheimer's disease.

PubMed

Doody, Rachelle S; Cole, Patricia E; Miller, David S; Siemers, Eric; Black, Ronald; Feldman, Howard; Schindler, Rachel; Graham, Stephen; Heath, Theresa; Khachaturian, Ara S; Evans, Rebecca; Carrillo, Maria C

2011-03-01

The number of clinical trials for Alzheimer's disease conducted outside the United States in a broad array of countries is increasing. As the number of compounds ready for clinical testing increases, and as trials become longer and more complex, this trend is expected to grow. The cultural and ethical context of global clinical trials, potential benefits for those involved, and practical approaches to obstacles generated by these global trials were discussed at a meeting of the Alzheimer's Association Research Roundtable. Regulatory issues, including regional differences in study registration procedures, rules for collecting and reporting serious adverse events, requirements for national identity of study populations, and regulatory audits were also discussed by individuals who are knowledgeable about global clinical trials for Alzheimer's disease. Copyright © 2011 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.
Intuition: A Concept Analysis.

PubMed

Chilcote, Deborah R

2017-01-01

The purpose of this article is to conceptually examine intuition; identify the importance of intuition in nursing education, clinical practice, and patient care; encourage acceptance of the use of intuition; and add to the body of nursing knowledge. Nurses often report using intuition when making clinical decisions. Intuition is a rapid, unconscious process based in global knowledge that views the patient holistically while synthesizing information to improve patient outcomes. However, with the advent of evidence-based practice (EBP), the use of intuition has become undervalued in nursing. Walker and Avant's framework was used to analyze intuition. A literature search from 1987 to 2014 was conducted using the following keywords: intuition, intuition and nursing, clinical decision making, clinical decision making and intuition, patient outcomes, EBP, and analytical thinking. The use of intuition is reported by nurses, but is not legitimized within the nursing profession. Defining attributes of intuition are an unconscious, holistic knowledge gathered without using an analytical process and knowledge derived through synthesis, not analysis. Consequences include verification of intuition through an analytical process and translating that knowledge into a course of action. This article supports the use of intuition in nursing by offering clarity to the concept, adds to the nursing knowledge base, encourages a holistic view of the patient during clinical decision making, and encourages nurse educators to promote the use of intuition. © 2016 Wiley Periodicals, Inc.

Calculating Clinically Significant Change: Applications of the Clinical Global Impressions (CGI) Scale to Evaluate Client Outcomes in Private Practice

ERIC Educational Resources Information Center

Kelly, Peter James

2010-01-01

The Clinical Global Impressions (CGI) scale is a therapist-rated measure of client outcome that has been widely used within the research literature. The current study aimed to develop reliable and clinically significant change indices for the CGI, and to demonstrate its application in private psychological practice. Following the guidelines…
Paediatric emergency and acute care in resource poor settings.

PubMed

Duke, Trevor; Cheema, Baljit

2016-02-01

Acute care of seriously ill children is a global public health issue, and there is much scope for improving quality of care in hospitals at all levels in many developing countries. We describe the current state of paediatric emergency and acute care in the least developed regions of low and middle income countries and identify gaps and requirements for improving quality. Approaches are needed which span the continuum of care: from triage and emergency treatment, the diagnostic process, identification of co-morbidities, treatment, monitoring and supportive care, discharge planning and follow-up. Improvements require support and training for health workers and quality processes. Effective training is that which is ongoing, combining good technical training in under-graduate courses and continuing professional development. Quality processes combine evidence-based guidelines, essential medicines, appropriate technology, appropriate financing of services, standards and assessment tools and training resources. While initial emergency treatment is based on common clinical syndromes, early differentiation is required for specific treatment, and this can usually be carried out clinically without expensive tests. While global strategies are important, it is what happens locally that makes a difference and is too often neglected. In rural areas in the poorest countries in the world, public doctors and nurses who provide emergency and acute care for children are revered by their communities and demonstrate daily that much can be carried out with little. © 2016 The Authors. Journal of Paediatrics and Child Health © 2016 Paediatrics and Child Health Division (Royal Australasian College of Physicians).
Comparing the Certification Criteria for CCHIT-Certified Ambulatory EHR with the SNUBH's EHR Functionalities

PubMed Central

Heo, Eun Young; Hwang, Hee; Kim, Eun Hye; Cho, Eun Young; Lee, Kee Hyuck; Kim, Tae Hun; Kim, Ki Dong; Baek, Rong Min

2012-01-01

Objectives This study aims to investigate the suitability of electronic health record (EHR) systems in Korea for global certification and to propose functions for future global systems by comparing and analyzing the certification criteria for Certification Commission for Health Information Technology (CCHIT) Certified Ambulatory EHR with BESTCare, which is the EHR system at Seoul National University Bundang hospital. Methods Domain expert groups were formed to analyze the inclusion of BESTCare functions and the types of differences for each of the CCHIT Certified 2011 Ambulatory EHR Certification Criteria. The types of differences were divided into differences in functions (F), differences in business processes (B), and differences in government policies (P). Results Generally, the criteria that showed differences in functions pertained to the connection between the diagnosis/problem list and order, the alert and warning functions for medication-diagnosis interactions, and the reminder/instruction/notification messages related to the patient's immunization status; these absent functions were enhanced clinical decision support system (CDSS) functions related to patient safety and healthcare quality. Differences in government policies were found in the pharmacy's electronic prescription functions, while differences in business processes were found in the functions constrained by the local workflow or internal policy, which require some customization. Conclusions Functions that differed between the CCHIT certification criteria and the BESTCare system in this study should be considered when developing a global EHR system. Such a system will need to be easily customizable to adapt to various government policies and local business processes. These functions should be considered when developing a global EHR system certified by CCHIT in the future. PMID:22509474
Higher levels of depression are associated with reduced global bias in visual processing.

PubMed

de Fockert, Jan W; Cooper, Andrew

2014-04-01

Negative moods have been associated with a tendency to prioritise local details in visual processing. The current study investigated the relation between depression and visual processing using the Navon task, a standard task of local and global processing. In the Navon task, global stimuli are presented that are made up of many local parts, and the participants are instructed to report the identity of either a global or a local target shape. Participants with a low self-reported level of depression showed evidence of the expected global processing bias, and were significantly faster at responding to the global, compared with the local level. By contrast, no such difference was observed in participants with high levels of depression. The reduction of the global bias associated with high levels of depression was only observed in the overall speed of responses to global (versus local) targets, and not in the level of interference produced by the global (versus local) distractors. These results are in line with recent findings of a dissociation between local/global processing bias and interference from local/global distractors, and support the claim that depression is associated with a reduction in the tendency to prioritise global-level processing.
Assessing commercial feasibility: a practical and ethical prerequisite for human clinical testing.

PubMed

Kirk, Dwayne D; Robert, Jason Scott

2005-01-01

This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons--particularly for orphan diseases without sufficient revenue incentive for industry investment--regardless of the effectiveness which might be demonstrated in human clinical testing. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. A model compromising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.
Preprocessing Raw Data in Clinical Medicine for a Data Mining Purpose

NASA Astrophysics Data System (ADS)

Peterková, Andrea; Michaľčonok, German

2016-12-01

Dealing with data from the field of medicine is nowadays very current and difficult. On a global scale, a large amount of medical data is produced on an everyday basis. For the purpose of our research, we understand medical data as data about patients like results from laboratory analysis, results from screening examinations (CT, ECHO) and clinical parameters. This data is usually in a raw format, difficult to understand, non-standard and not suitable for further processing or analysis. This paper aims to describe the possible method of data preparation and preprocessing of such raw medical data into a form, where further analysis algorithms can be applied.
Witnessing the effects of political violence in families: mechanisms of intergenerational transmission and clinical interventions.

PubMed

Weingarten, Kaethe

2004-01-01

In this era of globalization, when news about political violence can haunt anyone, anywhere, those whose families have suffered political violence in the past are particularly vulnerable to current distress. Skilled in understanding transgenerational processes, family therapists need to be familiar with the mechanisms by which children are exposed to the effects of political violence suffered by their elders-that is, the ways in which they become their witnesses. This article presents a framework for understanding how the trauma of political violence experienced in one generation can "pass" to another that did not directly experience it, and proposes a model to guide clinical intervention.
A time for new north–south relationships in global health

PubMed Central

Kim, Jin Un; Oleribe, Obinna; Njie, Ramou; Taylor-Robinson, Simon D

2017-01-01

The modern concept of globalization in health care and clinical research often carries a positive message for the “Global South” nations of Africa, South America and Southeast Asia. However, bioethical abuse of participants in clinical trials still exists in the Global South. Unethical studies directed by the “Global North”, formed by the medically advanced nations in North America, Western Europe and Japan, have been hugely concerning. The issue between the Global North and South is a well-recognized socioeconomic phenomenon of globalization. Medical exploitation has its roots in the socioeconomic interactions of a postcolonial world, and solutions to reducing exploitation require a deeper understanding of these societal models of globalization. We explore the fundamental causes of imbalance and suggest solutions. Reflecting on the globalization model, there must be an effort to empower the Global South nations to direct and govern their own health care systems efficiently on the basis of equality. PMID:29158688
Global Health and Emergency Care: Defining Clinical Research Priorities.

PubMed

Hansoti, Bhakti; Aluisio, Adam R; Barry, Meagan A; Davey, Kevin; Lentz, Brian A; Modi, Payal; Newberry, Jennifer A; Patel, Melissa H; Smith, Tricia A; Vinograd, Alexandra M; Levine, Adam C

2017-06-01

Despite recent strides in the development of global emergency medicine (EM), the field continues to lag in applying a scientific approach to identifying critical knowledge gaps and advancing evidence-based solutions to clinical and public health problems seen in emergency departments (EDs) worldwide. Here, progress on the global EM research agenda created at the 2013 Academic Emergency Medicine Global Health and Emergency Care Consensus Conference is evaluated and critical areas for future development in emergency care research internationally are identified. A retrospective review of all studies compiled in the Global Emergency Medicine Literature Review (GEMLR) database from 2013 through 2015 was conducted. Articles were categorized and analyzed using descriptive quantitative measures and structured data matrices. The Global Emergency Medicine Think Tank Clinical Research Working Group at the Society for Academic Emergency Medicine 2016 Annual Meeting then further conceptualized and defined global EM research priorities utilizing consensus-based decision making. Research trends in global EM research published between 2013 and 2015 show a predominance of observational studies relative to interventional or descriptive studies, with the majority of research conducted in the inpatient setting in comparison to the ED or prehospital setting. Studies on communicable diseases and injury were the most prevalent, with a relative dearth of research on chronic noncommunicable diseases. The Global Emergency Medicine Think Tank Clinical Research Working Group identified conceptual frameworks to define high-impact research priorities, including the traditional approach of using global burden of disease to define priorities and the impact of EM on individual clinical care and public health opportunities. EM research is also described through a population lens approach, including gender, pediatrics, and migrant and refugee health. Despite recent strides in global EM research and a proliferation of scholarly output in the field, further work is required to advocate for and inform research priorities in global EM. The priorities outlined in this paper aim to guide future research in the field, with the goal of advancing the development of EM worldwide. © 2017 by the Society for Academic Emergency Medicine.
Something has shifted: Nursing students' global perspective following international clinical placements.

PubMed

Gower, Shelley; Duggan, Ravani; Dantas, Jaya A R; Boldy, Duncan

2017-10-01

To examine understandings of global health issues among nursing students following participation in an international clinical placement during their pre-registration university education. Universities use international clinical placements, especially in developing countries, to develop cultural awareness in students; however, little is known about the longer term influences on students' understandings of global nursing. A retrospective cross-sectional design was used, using an exploratory, descriptive qualitative approach. Individual semi-structured interviews were conducted in 2014 with a purposive sample of 25 pre-registration nursing students from four Western Australian universities who undertook clinical placements across five countries. Data were analysed using inductive thematic analysis. Findings highlight that students developed new understandings around health systems including fragility of resource access, differences in clinical practice and variances in nursing roles between settings. Students also experienced challenges but were able to appreciate alternative world viewpoints. International clinical placements can develop greater awareness and help students form realistic strategies for using their nursing skills globally. Pre-placement training in cultural awareness and health system realities, along with strong supervisory support, is critical to success. © 2017 John Wiley & Sons Ltd.
Miniaturization and globalization of clinical laboratory activities.

PubMed

Melo, Murilo R; Clark, Samantha; Barrio, Daniel

2011-04-01

Clinical laboratories provide an invaluable service to millions of people around the world in the form of quality diagnostic care. Within the clinical laboratory industry the impetus for change has come from technological development (miniaturization, nanotechnology, and their collective effect on point-of-care testing; POCT) and the increasingly global nature of laboratory services. Potential technological gains in POCT include: the development of bio-sensors, microarrays, genetics and proteomics testing, and enhanced web connectivity. In globalization, prospective opportunities lie in: medical tourism, the migration of healthcare workers, cross-border delivery of testing, and the establishment of accredited laboratories in previously unexplored markets. Accompanying these impressive opportunities are equally imposing challenges. Difficulty transitioning from research to clinical use, poor infrastructure in developing countries, cultural differences and national barriers to global trade are only a few examples. Dealing with the issues presented by globalization and the impact of developing technology on POCT, and on the clinical laboratory services industry in general, will be a daunting task. Despite such concerns, with appropriate countermeasures it will be possible to address the challenges posed. Future laboratory success will be largely dependent on one's ability to adapt in this perpetually shifting landscape.
Mourning and psychosis: a psychoanalytic perspective.

PubMed

Tizón, Jorge L

2010-12-01

The author attempts to develop some of the basic models and concepts relating to mourning processes in psychotic patients on the assumption that situations of loss and mourning are key moments for psychoanalysis, psychotherapy, and therapeutic approaches in general. Secondly, he reminds us that 'mourning processes in psychotics' are not always 'psychotic mourning processes', that is to say, that they do not necessarily occur within, or give rise to, a psychotic clinical picture. These ideas are illustrated by a number of sessions and vignettes concerning two psychotic patients in psychotherapeutic and psychoanalytic treatment. In theoretical terms, it seems vitally important in this context to combine a relationship-based approach within a framework of special psychoanalytic psychopathology with an updated view of processes of mourning and affective loss. A fundamental requirement at clinical level is to determine the role to be played by psychoanalytically based treatments in combined, integrated or global therapies when working with psychotic patients. For this purpose, the paper ends by outlining a set of principles and objectives for such treatments. Copyright © 2010 Institute of Psychoanalysis.
Rapid communication: Global-local processing affects recognition of distractor emotional faces.

PubMed

Srinivasan, Narayanan; Gupta, Rashmi

2011-03-01

Recent studies have shown links between happy faces and global, distributed attention as well as sad faces to local, focused attention. Emotions have been shown to affect global-local processing. Given that studies on emotion-cognition interactions have not explored the effect of perceptual processing at different spatial scales on processing stimuli with emotional content, the present study investigated the link between perceptual focus and emotional processing. The study investigated the effects of global-local processing on the recognition of distractor faces with emotional expressions. Participants performed a digit discrimination task with digits at either the global level or the local level presented against a distractor face (happy or sad) as background. The results showed that global processing associated with broad scope of attention facilitates recognition of happy faces, and local processing associated with narrow scope of attention facilitates recognition of sad faces. The novel results of the study provide conclusive evidence for emotion-cognition interactions by demonstrating the effect of perceptual processing on emotional faces. The results along with earlier complementary results on the effect of emotion on global-local processing support a reciprocal relationship between emotional processing and global-local processing. Distractor processing with emotional information also has implications for theories of selective attention.
A framework to link international clinical research to the promotion of justice in global health.

PubMed

Pratt, Bridget; Loff, Bebe

2014-10-01

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high-income countries owed to parties from low and middle-income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The 'research for health justice' framework provides direction on three aspects of international clinical research: the research target, research capacity strengthening, and post-trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity. © 2012 John Wiley & Sons Ltd.
Evidence of Reduced Global Processing in Autism Spectrum Disorder

ERIC Educational Resources Information Center

Booth, Rhonda D. L.; Happé, Francesca G. E.

2018-01-01

Frith's original notion of 'weak central coherence' suggested that increased local processing in autism spectrum disorder (ASD) resulted from reduced global processing. More recent accounts have emphasised superior local perception and suggested intact global integration. However, tasks often place local and global processing in direct trade-off,…
Psychosocial factors partially mediate the relationship between mechanical hyperalgesia and self-reported pain.

PubMed

Mason, Kayleigh J; O'Neill, Terence W; Lunt, Mark; Jones, Anthony K P; McBeth, John

2018-01-26

Amplification of sensory signalling within the nervous system along with psychosocial factors contributes to the variation and severity of knee pain. Quantitative sensory testing (QST) is a non-invasive test battery that assesses sensory perception of thermal, pressure, mechanical and vibration stimuli used in the assessment of pain. Psychosocial factors also have an important role in explaining the occurrence of pain. The aim was to determine whether QST measures were associated with self-reported pain, and whether those associations were mediated by psychosocial factors. Participants with knee pain identified from a population-based cohort completed a tender point count and a reduced QST battery of thermal, mechanical and pressure pain thresholds, temporal summation, mechanical pain sensitivity (MPS), dynamic mechanical allodynia (DMA) and vibration detection threshold performed following the protocol by the German Research Network on Neuropathic Pain. QST assessments were performed at the most painful knee and opposite forearm (if pain-free). Participants were asked to score for their global and knee pain intensities within the past month (range 0-10), and complete questionnaire items investigating anxiety, depression, illness perceptions, pain catastrophising, and physical functioning. QST measures (independent variable) significantly correlated (Spearman's rho) with self-reported pain intensity (dependent variable) were included in structural equation models with psychosocial factors (latent mediators). Seventy-two participants were recruited with 61 participants (36 women; median age 64 years) with complete data included in subsequent analyses. Tender point count was significantly correlated with global pain intensity. DMA at the knee and MPS at the most painful knee and opposite pain-free forearm were significantly correlated with both global pain and knee pain intensities. Psychosocial factors including pain catastrophising sub-scales (rumination and helplessness) and illness perceptions (consequences and concern) were significant partial mediators of the association with global pain intensity when loaded on to a latent mediator for: tender point count [75% total effect; 95% confidence interval (CI) 22%, 100%]; MPS at the knee (49%; 12%, 86%); and DMA at the knee (63%; 5%, 100%). Latent psychosocial factors were also significant partial mediators of the association between pain intensity at the tested knee with MPS at the knee (30%; 2%, 58%), but not for DMA at the knee. Measures of mechanical hyperalgesia at the most painful knee and pain-free opposite forearm were associated with increased knee and global pain indicative of altered central processing. Psychosocial factors were significant partial mediators, highlighting the importance of the central integration of emotional processing in pain perception. Associations between mechanical hyperalgesia at the forearm and knee, psychosocial factors and increased levels of clinical global and knee pain intensity provide evidence of altered central processing as a key mechanism in knee pain, with psychological factors playing a key role in the expression of clinical pain.
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need

PubMed Central

Trusheim, M; Cobbs, E; Bala, M; Garner, S; Hartman, D; Isaacs, K; Lumpkin, M; Lim, R; Oye, K; Pezalla, E; Saltonstall, P; Selker, H

2016-01-01

The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose to address this gap by reengineering innovation processes to accelerate reliable delivery of products that address unmet medical needs. Adaptive biomedical innovation (ABI) provides an integrative, strategic approach for process innovation. Although the term “ABI” is new, it encompasses fragmented “tools” that have been developed across the global pharmaceutical industry, and could accelerate the evolution of the system through more coordinated application. ABI involves bringing stakeholders together to set shared objectives, foster trust, structure decision‐making, and manage expectations through rapid‐cycle feedback loops that maximize product knowledge and reduce uncertainty in a continuous, adaptive, and sustainable learning healthcare system. Adaptive decision‐making, a core element of ABI, provides a framework for structuring decision‐making designed to manage two types of uncertainty – the maturity of scientific and clinical knowledge, and the behaviors of other critical stakeholders. PMID:27626610
Engaging with clinicians to implement and evaluate the ICF in neurorehabilitation practice.

PubMed

Tempest, Stephanie; Jefferson, Richard

2015-01-01

Although deemed a globally accepted framework, there remains scare evidence on the process and outcome of implementing the International Classification of Functioning, Disability and Health (ICF) within neurorehabilitation. This review briefly explores the existing, broader literature and then reports on two action research projects, undertaken in England, specifically within stroke and neurorehabilitation. Working with participants, including clinicians from in-patient and community settings, there are now 35 different ways identified for the use of the ICF. The outcome of the first project highlights that using the ICF enhances communication within and beyond the acute stroke service, fosters holistic thinking and clarifies team roles. To adopt it into clinical practice, the ICF must be adapted to meet local service needs. The use of action research has facilitated the knowledge translation process which has enabled the ICF to become a clinical reality in neurorehabilitation, with clinicians identifying a range of potential uses.
QNOTE: an instrument for measuring the quality of EHR clinical notes.

PubMed

Burke, Harry B; Hoang, Albert; Becher, Dorothy; Fontelo, Paul; Liu, Fang; Stephens, Mark; Pangaro, Louis N; Sessums, Laura L; O'Malley, Patrick; Baxi, Nancy S; Bunt, Christopher W; Capaldi, Vincent F; Chen, Julie M; Cooper, Barbara A; Djuric, David A; Hodge, Joshua A; Kane, Shawn; Magee, Charles; Makary, Zizette R; Mallory, Renee M; Miller, Thomas; Saperstein, Adam; Servey, Jessica; Gimbel, Ronald W

2014-01-01

The outpatient clinical note documents the clinician's information collection, problem assessment, and patient management, yet there is currently no validated instrument to measure the quality of the electronic clinical note. This study evaluated the validity of the QNOTE instrument, which assesses 12 elements in the clinical note, for measuring the quality of clinical notes. It also compared its performance with a global instrument that assesses the clinical note as a whole. Retrospective multicenter blinded study of the clinical notes of 100 outpatients with type 2 diabetes mellitus who had been seen in clinic on at least three occasions. The 300 notes were rated by eight general internal medicine and eight family medicine practicing physicians. The QNOTE instrument scored the quality of the note as the sum of a set of 12 note element scores, and its inter-rater agreement was measured by the intraclass correlation coefficient. The Global instrument scored the note in its entirety, and its inter-rater agreement was measured by the Fleiss κ. The overall QNOTE inter-rater agreement was 0.82 (CI 0.80 to 0.84), and its note quality score was 65 (CI 64 to 66). The Global inter-rater agreement was 0.24 (CI 0.19 to 0.29), and its note quality score was 52 (CI 49 to 55). The QNOTE quality scores were consistent, and the overall QNOTE score was significantly higher than the overall Global score (p=0.04). We found the QNOTE to be a valid instrument for evaluating the quality of electronic clinical notes, and its performance was superior to that of the Global instrument. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
In Vivo Assessment of Protease Dynamics in Cutaneous Wound Healing by Degradomics Analysis of Porcine Wound Exudates*

PubMed Central

Sabino, Fabio; Hermes, Olivia; Egli, Fabian E.; Kockmann, Tobias; Schlage, Pascal; Croizat, Pierre; Kizhakkedathu, Jayachandran N.; Smola, Hans; auf dem Keller, Ulrich

2015-01-01

Proteases control complex tissue responses by modulating inflammation, cell proliferation and migration, and matrix remodeling. All these processes are orchestrated in cutaneous wound healing to restore the skin's barrier function upon injury. Altered protease activity has been implicated in the pathogenesis of healing impairments, and proteases are important targets in diagnosis and therapy of this pathology. Global assessment of proteolysis at critical turning points after injury will define crucial events in acute healing that might be disturbed in healing disorders. As optimal biospecimens, wound exudates contain an ideal proteome to detect extracellular proteolytic events, are noninvasively accessible, and can be collected at multiple time points along the healing process from the same wound in the clinics. In this study, we applied multiplexed Terminal Amine Isotopic Labeling of Substrates (TAILS) to globally assess proteolysis in early phases of cutaneous wound healing. By quantitative analysis of proteins and protein N termini in wound fluids from a clinically relevant pig wound model, we identified more than 650 proteins and discerned major healing phases through distinctive abundance clustering of markers of inflammation, granulation tissue formation, and re-epithelialization. TAILS revealed a high degree of proteolysis at all time points after injury by detecting almost 1300 N-terminal peptides in ∼450 proteins. Quantitative positional proteomics mapped pivotal interdependent processing events in the blood coagulation and complement cascades, temporally discerned clotting and fibrinolysis during the healing process, and detected processing of complement C3 at distinct time points after wounding and by different proteases. Exploiting data on primary cleavage specificities, we related candidate proteases to cleavage events and revealed processing of the integrin adapter protein kindlin-3 by caspase-3, generating new hypotheses for protease-substrate relations in the healing skin wound in vivo. The data have been deposited to the ProteomeXchange Consortium with identifier PXD001198. PMID:25516628

The tendency of unconscious thought toward global processing style.

PubMed

Li, Jiansheng; Wang, Fan; Shen, Mowei; Fan, Gang

2017-08-01

This study explored whether unconscious thought has a tendency to process information globally. In three experiments, a Navon task was used to activate global or local processing styles. Findings showed that in the unconscious-thought groups, those performing the local Navon task presented a poorer decision-making performance when compared to those performing the global Navon task (Experiment 1); participants reported that their judgments were made based on partial attributes (Experiment 2), and evaluated a target individual mainly based on information consistent with stereotypes (Experiment 3). These results showed that when presented with distracter tasks, conscious thought activates local processing, which impairs its ability to process information globally. However, this impairment would not happen if global processing were activated instead. This study provides support to the idea that unconscious thought has a tendency to process information globally. Copyright © 2017 Elsevier Inc. All rights reserved.
New Therapeutic Uses for Existing Drugs.

PubMed

Austin, Bobbie Ann; Gadhia, Ami D

2017-01-01

Eighty percent of drugs that enter human clinical testing are never approved for use. This means that for every five drugs that make it into the clinic, there are four that failed to show effectiveness for treating the disease or condition the drug was designed to treat.This high failure rate means there are many existing, partially developed therapeutic candidates with known pharmacology, formulation, and potential toxicity. Finding new uses for existing experimental drugs or biologics "repositioning" builds upon previous research and development efforts, so new candidate therapies can be advanced to clinical trials for a new use more quickly than starting from scratch.Federal funding initiatives in the U.S. and UK started to support pre-clinical /or early stage trials for repositioning existing experimental drugs or biologics (therapies). This chapter covers some of the process issues that have been solved and the remaining challenges that are still in need of solutions. The chapter is primarily written from a U.S. federal funding perspective. The general concepts could be applied more globally to benefit rare and neglected disease populations. The drug development and process bottlenecks are the same for both rare and common disease.
Autism: Hard to Switch from Details to the Whole.

PubMed

Soriano, María Felipa; Ibáñez-Molina, Antonio J; Paredes, Natalia; Macizo, Pedro

2017-12-18

It has long been proposed that individuals with autism exhibit a superior processing of details at the expense of an impaired global processing. This theory has received some empirical support, but results are mixed. In this research we have studied local and global processing in ASD and Typically Developing children, with an adaptation of the Navon task, designed to measure congruency effects between local and global stimuli and switching cost between local and global tasks. ASD children showed preserved global processing; however, compared to Typically Developing children, they exhibited more facilitation from congruent local stimuli when they performed the global task. In addition, children with ASD had more switching cost than Typically Developing children only when they switched from the local to the global task, reflecting a specific difficulty to disengage from local stimuli. Together, results suggest that ASD is characterized by a tendency to process local details, they benefit from the processing of local stimuli at the expense of increasing cost to disengage from local stimuli when global processing is needed. Thus, this work demonstrates experimentally the advantages and disadvantages of the increased local processing in children with ASD.
Local and Global Auditory Processing: Behavioral and ERP Evidence

PubMed Central

Sanders, Lisa D.; Poeppel, David

2007-01-01

Differential processing of local and global visual features is well established. Global precedence effects, differences in event-related potentials (ERPs) elicited when attention is focused on local versus global levels, and hemispheric specialization for local and global features all indicate that relative scale of detail is an important distinction in visual processing. Observing analogous differential processing of local and global auditory information would suggest that scale of detail is a general organizational principle of the brain. However, to date the research on auditory local and global processing has primarily focused on music perception or on the perceptual analysis of relatively higher and lower frequencies. The study described here suggests that temporal aspects of auditory stimuli better capture the local-global distinction. By combining short (40 ms) frequency modulated tones in series to create global auditory patterns (500 ms), we independently varied whether pitch increased or decreased over short time spans (local) and longer time spans (global). Accuracy and reaction time measures revealed better performance for global judgments and asymmetric interference that were modulated by amount of pitch change. ERPs recorded while participants listened to identical sounds and indicated the direction of pitch change at the local or global levels provided evidence for differential processing similar to that found in ERP studies employing hierarchical visual stimuli. ERP measures failed to provide evidence for lateralization of local and global auditory perception, but differences in distributions suggest preferential processing in more ventral and dorsal areas respectively. PMID:17113115
Classifying nursing errors in clinical management within an Australian hospital.

PubMed

Tran, D T; Johnson, M

2010-12-01

Although many classification systems relating to patient safety exist, no taxonomy was identified that classified nursing errors in clinical management. To develop a classification system for nursing errors relating to clinical management (NECM taxonomy) and to describe contributing factors and patient consequences. We analysed 241 (11%) self-reported incidents relating to clinical management in nursing in a metropolitan hospital. Descriptive analysis of numeric data and content analysis of text data were undertaken to derive the NECM taxonomy, contributing factors and consequences for patients. Clinical management incidents represented 1.63 incidents per 1000 occupied bed days. The four themes of the NECM taxonomy were nursing care process (67%), communication (22%), administrative process (5%), and knowledge and skill (6%). Half of the incidents did not cause any patient harm. Contributing factors (n=111) included the following: patient clinical, social conditions and behaviours (27%); resources (22%); environment and workload (18%); other health professionals (15%); communication (13%); and nurse's knowledge and experience (5%). The NECM taxonomy provides direction to clinicians and managers on areas in clinical management that are most vulnerable to error, and therefore, priorities for system change management. Any nurses who wish to classify nursing errors relating to clinical management could use these types of errors. This study informs further research into risk management behaviour, and self-assessment tools for clinicians. Globally, nurses need to continue to monitor and act upon patient safety issues. © 2010 The Authors. International Nursing Review © 2010 International Council of Nurses.
World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project: IV. Tissue collection, processing, and storage in endometriosis research

PubMed Central

Fassbender, Amelie; Rahmioglu, Nilufer; Vitonis, Allison F.; Viganò, Paola; Giudice, Linda C.; D’Hooghe, Thomas M.; Hummelshoj, Lone; Adamson, G. David; Becker, Christian M.; Missmer, Stacey A.; Zondervan, Krina T.; Adamson, G.D.; Allaire, C.; Anchan, R.; Becker, C.M.; Bedaiwy, M.A.; Buck Louis, G.M.; Calhaz-Jorge, C.; Chwalisz, K.; D'Hooghe, T.M.; Fassbender, A.; Faustmann, T.; Fazleabas, A.T.; Flores, I.; Forman, A.; Fraser, I.; Giudice, L.C.; Gotte, M.; Gregersen, P.; Guo, S.-W.; Harada, T.; Hartwell, D.; Horne, A.W.; Hull, M.L.; Hummelshoj, L.; Ibrahim, M.G.; Kiesel, L.; Laufer, M.R.; Machens, K.; Mechsner, S.; Missmer, S.A.; Montgomery, G.W.; Nap, A.; Nyegaard, M.; Osteen, K.G.; Petta, C.A.; Rahmioglu, N.; Renner, S.P.; Riedlinger, J.; Roehrich, S.; Rogers, P.A.; Rombauts, L.; Salumets, A.; Saridogan, E.; Seckin, T.; Stratton, P.; Sharpe-Timms, K.L.; Tworoger, S.; Vigano, P.; Vincent, K.; Vitonis, A.F.; Wienhues-Thelen, U.-H.; Yeung, P.P.; Yong, P.; Zondervan, K.T.

2014-01-01

Objective To harmonize standard operating procedures (SOPs) and standardize the recording of associated data for collection, processing, and storage of human tissues relevant to endometriosis. Design An international collaboration involving 34 clinical/academic centers and three industry collaborators from 16 countries on five continents. Setting In 2013, two workshops were conducted followed by global consultation, bringing together 54 leaders in endometriosis research and sample processing from around the world. Patient(s) None. Intervention(s) Consensus SOPs were based on: 1) systematic comparison of SOPs from 24 global centers collecting tissue samples from women with and without endometriosis on a medium or large scale (publication on >100 cases); 2) literature evidence where available, or consultation with laboratory experts otherwise; and 3) several global consultation rounds. Main Outcome Measure(s) Standard recommended and minimum required SOPs for tissue collection, processing, and storage in endometriosis research. Result(s) We developed “recommended standard” and “minimum required” SOPs for the collection, processing, and storage of ectopic and eutopic endometrium, peritoneum, and myometrium, and a biospecimen data collection form necessary for interpretation of sample-derived results. Conclusion(s) The EPHect SOPs allow endometriosis research centers to decrease variability in tissue-based results, facilitating between-center comparisons and collaborations. The procedures are also relevant to research into other gynecologic conditions involving endometrium, myometrium, and peritoneum. The consensus SOPs are based on the best available evidence; areas with limited evidence are identified as requiring further pilot studies. The SOPs will be reviewed based on investigator feedback and through systematic triannual follow-up. Updated versions will be made available at: http://endometriosisfoundation.org/ephect. PMID:25256928
Global processing takes time: A meta-analysis on local-global visual processing in ASD.

PubMed

Van der Hallen, Ruth; Evers, Kris; Brewaeys, Katrien; Van den Noortgate, Wim; Wagemans, Johan

2015-05-01

What does an individual with autism spectrum disorder (ASD) perceive first: the forest or the trees? In spite of 30 years of research and influential theories like the weak central coherence (WCC) theory and the enhanced perceptual functioning (EPF) account, the interplay of local and global visual processing in ASD remains only partly understood. Research findings vary in indicating a local processing bias or a global processing deficit, and often contradict each other. We have applied a formal meta-analytic approach and combined 56 articles that tested about 1,000 ASD participants and used a wide range of stimuli and tasks to investigate local and global visual processing in ASD. Overall, results show no enhanced local visual processing nor a deficit in global visual processing. Detailed analysis reveals a difference in the temporal pattern of the local-global balance, that is, slow global processing in individuals with ASD. Whereas task-dependent interaction effects are obtained, gender, age, and IQ of either participant groups seem to have no direct influence on performance. Based on the overview of the literature, suggestions are made for future research. (c) 2015 APA, all rights reserved).
Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011-2013.

PubMed

Jeong, Sohyun; Sohn, Minji; Kim, Jae Hyun; Ko, Minoh; Seo, Hee-Won; Song, Yun-Kyoung; Choi, Boyoon; Han, Nayoung; Na, Han-Sung; Lee, Jong Gu; Kim, In-Wha; Oh, Jung Mi; Lee, Euni

2017-06-21

Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013. The data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis. The USA, Germany, France, Canada, and United Kingdom were the "top five" countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p < 0.001) while phase 3 trials were much more prevalent in all nine representative countries than in the USA. A larger number of "child" age group trials was performed in Poland (OR 1.852, p < 0.001), Israel (OR 1.546, p = 0.005), and South Africa (OR 1.963, p < 0.001) than in the USA. Multivariate analysis showed that health care expenditure per capita, Economic Freedom Index, Human Capital Index, and Intellectual Property Rights Index could explain the variance of regional distribution of clinical trials by 63.6%. The globalization of clinical trials in the emerging regions of Asia, South Africa, and Eastern Europe developed in parallel with the factors of economic drive, population for recruitment, and regulatory constraints.
Comparative study of group treatments for posttraumatic stress disorder.

PubMed

Maxwell, Kendal; Callahan, Jennifer L; Holtz, Pamela; Janis, Beth M; Gerber, Monica M; Connor, Dana R

2016-12-01

Presented herein is a comparative study of group treatments for posttraumatic stress disorder (PTSD). In this study, an emerging intervention, memory specificity training (MeST), was compared with cognitive processing therapy (CPT) using standardized outcome measures of target symptoms (i.e., anxiety and depression from client perspective; memory specificity from independent rater perspective) and global functioning (independent rater perspective), as well as a process measure of expectancy (client perspective). Clients were assessed on 3 separate occasions: at baseline, posttreatment, and 3 months posttreatment. Adherence and treatment fidelity (independent rater perspective) were monitored throughout the course of both treatment conditions. Improvement in PTSD symptoms, depressive symptoms, and global functioning were similar between MeST and CPT; an increase in ability to specify memories upon retrieval was also similar between MeST and CPT. Positive reliable change was observed in both groups on all outcome measures. With respect to the primary target of PTSD symptoms, 88% of participants in both treatment groups moved into the functional distribution by posttreatment and maintained these gains at follow-up. Notably, compared with CPT, MeST required only half the dosage (i.e., number of sessions) to accomplish these gains. Illustrative vignettes from client-therapist exchanges are provided, and results are discussed in terms of the potential mechanisms of action. Implications for both clinical practice and clinical research are also included. (PsycINFO Database Record (c) 2016 APA, all rights reserved).
Executive summary—Biomarkers of Nutrition for Development: Building a Consensus123

PubMed Central

Namasté, Sorrel; Brabin, Bernard; Combs, Gerald; L'Abbe, Mary R; Wasantwisut, Emorn; Darnton-Hill, Ian

2011-01-01

The ability to develop evidence-based clinical guidance and effective programs and policies to achieve global health promotion and disease prevention goals depends on the availability of valid and reliable data. With specific regard to the role of food and nutrition in achieving those goals, relevant data are developed with the use of biomarkers that reflect nutrient exposure, status, and functional effect. A need exists to promote the discovery, development, and use of biomarkers across a range of applications. In addition, a process is needed to harmonize the global health community's decision making about what biomarkers are best suited for a given use under specific conditions and settings. To address these needs, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, US Department of Health and Human Services, organized a conference entitled “Biomarkers of Nutrition for Development: Building a Consensus,” which was hosted by the International Atomic Energy Agency. Partners included key multilateral, US agencies and public and private organizations. The assembly endorsed the utility of this initiative and the need for the BOND (Biomarkers of Nutrition for Development) project to continue. A consensus was reached on the requirement to develop a process to inform the community about the relative strengths or weaknesses and specific applications of various biomarkers under defined conditions. The articles in this supplement summarize the deliberations of the 4 working groups: research, clinical, policy, and programmatic. Also described are content presentations on the harmonization processes, the evidence base for biomarkers for 5 case-study micronutrients, and new frontiers in science and technology. PMID:21733880
Can modeling of HIV treatment processes improve outcomes? Capitalizing on an operations research approach to the global pandemic

PubMed Central

Xiong, Wei; Hupert, Nathaniel; Hollingsworth, Eric B; O'Brien, Megan E; Fast, Jessica; Rodriguez, William R

2008-01-01

Background Mathematical modeling has been applied to a range of policy-level decisions on resource allocation for HIV care and treatment. We describe the application of classic operations research (OR) techniques to address logistical and resource management challenges in HIV treatment scale-up activities in resource-limited countries. Methods We review and categorize several of the major logistical and operational problems encountered over the last decade in the global scale-up of HIV care and antiretroviral treatment for people with AIDS. While there are unique features of HIV care and treatment that pose significant challenges to effective modeling and service improvement, we identify several analogous OR-based solutions that have been developed in the service, industrial, and health sectors. Results HIV treatment scale-up includes many processes that are amenable to mathematical and simulation modeling, including forecasting future demand for services; locating and sizing facilities for maximal efficiency; and determining optimal staffing levels at clinical centers. Optimization of clinical and logistical processes through modeling may improve outcomes, but successful OR-based interventions will require contextualization of response strategies, including appreciation of both existing health care systems and limitations in local health workforces. Conclusion The modeling techniques developed in the engineering field of operations research have wide potential application to the variety of logistical problems encountered in HIV treatment scale-up in resource-limited settings. Increasing the number of cross-disciplinary collaborations between engineering and public health will help speed the appropriate development and application of these tools. PMID:18680594
Genomic and Phenotypic Characterization of Vibrio cholerae Non-O1 Isolates from a US Gulf Coast Cholera Outbreak

PubMed Central

Grim, Christopher J.; Onifade, Tiffiani J.; Cinar, Hediye N.; Tall, Ben D.; Taviani, Elisa; Hasan, Nur A.; Abdullah, AbdulShakur H.; Carter, Laurenda; Sahu, Surasri N.; Kothary, Mahendra H.; Chen, Arlene; Baker, Ron; Hutchinson, Richard; Blackmore, Carina; Cebula, Thomas A.; Huq, Anwar; Colwell, Rita R.

2014-01-01

Between November 2010, and May 2011, eleven cases of cholera, unrelated to a concurrent outbreak on the island of Hispaniola, were recorded, and the causative agent, Vibrio cholerae serogroup O75, was traced to oysters harvested from Apalachicola Bay, Florida. From the 11 diagnosed cases, eight isolates of V. cholerae were isolated and their genomes were sequenced. Genomic analysis demonstrated the presence of a suite of mobile elements previously shown to be involved in the disease process of cholera (ctxAB, VPI-1 and -2, and a VSP-II like variant) and a phylogenomic analysis showed the isolates to be sister taxa to toxigenic V. cholerae V51 serogroup O141, a clinical strain isolated 23 years earlier. Toxigenic V. cholerae O75 has been repeatedly isolated from clinical cases in the southeastern United States and toxigenic V. cholerae O141 isolates have been isolated globally from clinical cases over several decades. Comparative genomics, phenotypic analyses, and a Caenorhabditis elegans model of infection for the isolates were conducted. This analysis coupled with isolation data of V. cholerae O75 and O141 suggests these strains may represent an underappreciated clade of cholera-causing strains responsible for significant disease burden globally. PMID:24699521
Genomic and phenotypic characterization of Vibrio cholerae non-O1 isolates from a US Gulf Coast cholera outbreak.

PubMed

Haley, Bradd J; Choi, Seon Young; Grim, Christopher J; Onifade, Tiffiani J; Cinar, Hediye N; Tall, Ben D; Taviani, Elisa; Hasan, Nur A; Abdullah, Abdulshakur H; Carter, Laurenda; Sahu, Surasri N; Kothary, Mahendra H; Chen, Arlene; Baker, Ron; Hutchinson, Richard; Blackmore, Carina; Cebula, Thomas A; Huq, Anwar; Colwell, Rita R

2014-01-01

Between November 2010, and May 2011, eleven cases of cholera, unrelated to a concurrent outbreak on the island of Hispaniola, were recorded, and the causative agent, Vibrio cholerae serogroup O75, was traced to oysters harvested from Apalachicola Bay, Florida. From the 11 diagnosed cases, eight isolates of V. cholerae were isolated and their genomes were sequenced. Genomic analysis demonstrated the presence of a suite of mobile elements previously shown to be involved in the disease process of cholera (ctxAB, VPI-1 and -2, and a VSP-II like variant) and a phylogenomic analysis showed the isolates to be sister taxa to toxigenic V. cholerae V51 serogroup O141, a clinical strain isolated 23 years earlier. Toxigenic V. cholerae O75 has been repeatedly isolated from clinical cases in the southeastern United States and toxigenic V. cholerae O141 isolates have been isolated globally from clinical cases over several decades. Comparative genomics, phenotypic analyses, and a Caenorhabditis elegans model of infection for the isolates were conducted. This analysis coupled with isolation data of V. cholerae O75 and O141 suggests these strains may represent an underappreciated clade of cholera-causing strains responsible for significant disease burden globally.
The Mental Health Recovery Measure Can Be Used to Assess Aspects of Both Customer-Based and Service-Based Recovery in the Context of Severe Mental Illness.

PubMed

Oliveira-Maia, Albino J; Mendonça, Carina; Pessoa, Maria J; Camacho, Marta; Gago, Joaquim

2016-01-01

Within clinical psychiatry, recovery from severe mental illness (SMI) has classically been defined according to symptoms and function (service-based recovery). However, service-users have argued that recovery should be defined as the process of overcoming mental illness, regaining self-control and establishing a meaningful life (customer-based recovery). Here, we aimed to compare customer-based and service-based recovery and clarify their differential relationship with other constructs, namely needs and quality of life. The study was conducted in 101 patients suffering from SMI, recruited from a rural community mental health setting in Portugal. Customer-based recovery and function-related service-based recovery were assessed, respectively, using a shortened version of the Mental Health Recovery Measure (MHRM-20) and the Global Assessment of Functioning score. The Camberwell Assessment of Need scale was used to objectively assess needs, while subjective quality of life was measured with the TL-30s scale. Using multiple linear regression models, we found that the Global Assessment of Functioning score was incrementally predictive of the MHRM-20 score, when added to a model including only clinical and demographic factors, and that this model was further incremented by the score for quality of life. However, in an alternate model using the Global Assessment of Functioning score as the dependent variable, while the MHRM-20 score contributed significantly to the model when added to clinical and demographic factors, the model was not incremented by the score for quality of life. These results suggest that, while a more global concept of recovery from SMI may be assessed using measures for service-based and customer-based recovery, the latter, namely the MHRM-20, also provides information about subjective well-being. Pending confirmation of these findings in other populations, this instrument could thus be useful for comprehensive assessment of recovery and subjective well-being in patients suffering from SMI.
The Mental Health Recovery Measure Can Be Used to Assess Aspects of Both Customer-Based and Service-Based Recovery in the Context of Severe Mental Illness

PubMed Central

Oliveira-Maia, Albino J.; Mendonça, Carina; Pessoa, Maria J.; Camacho, Marta; Gago, Joaquim

2016-01-01

Within clinical psychiatry, recovery from severe mental illness (SMI) has classically been defined according to symptoms and function (service-based recovery). However, service-users have argued that recovery should be defined as the process of overcoming mental illness, regaining self-control and establishing a meaningful life (customer-based recovery). Here, we aimed to compare customer-based and service-based recovery and clarify their differential relationship with other constructs, namely needs and quality of life. The study was conducted in 101 patients suffering from SMI, recruited from a rural community mental health setting in Portugal. Customer-based recovery and function-related service-based recovery were assessed, respectively, using a shortened version of the Mental Health Recovery Measure (MHRM-20) and the Global Assessment of Functioning score. The Camberwell Assessment of Need scale was used to objectively assess needs, while subjective quality of life was measured with the TL-30s scale. Using multiple linear regression models, we found that the Global Assessment of Functioning score was incrementally predictive of the MHRM-20 score, when added to a model including only clinical and demographic factors, and that this model was further incremented by the score for quality of life. However, in an alternate model using the Global Assessment of Functioning score as the dependent variable, while the MHRM-20 score contributed significantly to the model when added to clinical and demographic factors, the model was not incremented by the score for quality of life. These results suggest that, while a more global concept of recovery from SMI may be assessed using measures for service-based and customer-based recovery, the latter, namely the MHRM-20, also provides information about subjective well-being. Pending confirmation of these findings in other populations, this instrument could thus be useful for comprehensive assessment of recovery and subjective well-being in patients suffering from SMI. PMID:27857698
Challenges to Global Implementation of Infrared Thermography Technology: Current Perspective

PubMed Central

Shterenshis, Michael

2017-01-01

Medical infrared thermography (IT) produces an image of the infrared waves emitted by the human body as part of the thermoregulation process that can vary in intensity based on the health of the person. This review analyzes recent developments in the use of infrared thermography as a screening and diagnostic tool in clinical and nonclinical settings, and identifies possible future routes for improvement of the method. Currently, infrared thermography is not considered to be a fully reliable diagnostic method. If standard infrared protocol is established and a normative database is available, infrared thermography may become a reliable method for detecting inflammatory processes. PMID:29138741
Challenges to Global Implementation of Infrared Thermography Technology: Current Perspective.

PubMed

Shterenshis, Michael

2017-01-01

Medical infrared thermography (IT) produces an image of the infrared waves emitted by the human body as part of the thermoregulation process that can vary in intensity based on the health of the person. This review analyzes recent developments in the use of infrared thermography as a screening and diagnostic tool in clinical and nonclinical settings, and identifies possible future routes for improvement of the method. Currently, infrared thermography is not considered to be a fully reliable diagnostic method. If standard infrared protocol is established and a normative database is available, infrared thermography may become a reliable method for detecting inflammatory processes.
The rationale/design of the Guimarães/Vizela study: a multimodal population-based cohort study to determine global cardiovascular risk and disease.

PubMed

Cunha, Pedro Guimarães; Cotter, Jorge; Oliveira, Pedro; Vila, Isabel; Sousa, Nuno

2014-06-01

Cardiovascular disease and dementia are growing medical and social problems in aging societies. Appropriate knowledge of cardiovascular disease and cognitive decline risk factors (RFs) are critical for global CVR health preventive intervention. Many epidemiological studies use case definition based on data collected/measured in a single visit, a fact that can overestimate prevalence rates and distant from clinical practice demanding criteria. Portugal displays an elevated stroke mortality rate. However, population's global CV risk characterization is limited, namely, considering traditional/nontraditional RF and new intermediate phenotypes of CV and renal disease. Association of hemodynamic variables (pulse wave velocity and central blood pressure) with global CVR stratification, cognitive performance, and kidney disease are practically inexistent at a dwelling population level. After reviewing published data, we designed a population-based cohort study to analyze the prevalence of these cardiovascular RFs and intermediate phenotypes, using random sampling of adult dwellers living in 2 adjacent cities. Strict definition of phenotypes was planned: subjects were observed twice, and several hemodynamic and other biological variables measured at least 3 months apart. Three thousand thirty-eight subjects were enrolled, and extensive data collection (including central and peripheral blood pressure, pulse wave velocity), sample processing, and biobank edification were carried out. One thousand forty-seven cognitive evaluations were performed. Seeking for CV risk reclassification, early identification of subjects at risk, and evidence of early vascular aging and cognitive and renal function decline, using the strict daily clinical practice criteria, will lead to better resource allocation in preventive measures at a population level.
Migratory potential of transplanted glial progenitors as critical factor for successful translation of glia replacement therapy: The gap between mice and men.

PubMed

Srivastava, Rohit K; Bulte, Jeff W M; Walczak, Piotr; Janowski, Miroslaw

2018-05-01

Neurological disorders are a major threat to public health. Stem cell-based regenerative medicine is now a promising experimental paradigm for its treatment, as shown in pre-clinical animal studies. Initial attempts have been on the replacement of neuronal cells only, but glial progenitors (GPs) are now becoming strong alternative cellular therapeutic candidates to replace oligodendrocytes and astrocytes as knowledge accumulates about their important emerging role in various disease processes. There are many examples of successful therapeutic outcomes for transplanted GPs in small animal models, but clinical translation has proved to be challenging due to the 1,000-fold larger volume of the human brain compared to mice. Human GPs transplanted into the mouse brain migrate extensively and can induce global cell replacement, but a similar extent of migration in the human brain would only allow for local rather than global cell replacement. We review here the mechanisms that govern cell migration, which could potentially be exploited to enhance the migratory properties of GPs through cell engineering pre-transplantation. We furthermore discuss the (dis)advantages of the various cell delivery routes that are available, with particular emphasis on intra-arterial injection as the most suitable route for achieving global cell distribution in the larger brain. Now that therapeutic success has proven to be feasible in small animal models, future efforts will need to be directed to enhance global cell delivery and migration to make bench-to-bedside translation a reality. © 2017 Wiley Periodicals, Inc.
Global processing in amblyopia: a review

PubMed Central

Hamm, Lisa M.; Black, Joanna; Dai, Shuan; Thompson, Benjamin

2014-01-01

Amblyopia is a neurodevelopmental disorder of the visual system that is associated with disrupted binocular vision during early childhood. There is evidence that the effects of amblyopia extend beyond the primary visual cortex to regions of the dorsal and ventral extra-striate visual cortex involved in visual integration. Here, we review the current literature on global processing deficits in observers with either strabismic, anisometropic, or deprivation amblyopia. A range of global processing tasks have been used to investigate the extent of the cortical deficit in amblyopia including: global motion perception, global form perception, face perception, and biological motion. These tasks appear to be differentially affected by amblyopia. In general, observers with unilateral amblyopia appear to show deficits for local spatial processing and global tasks that require the segregation of signal from noise. In bilateral cases, the global processing deficits are exaggerated, and appear to extend to specialized perceptual systems such as those involved in face processing. PMID:24987383

[Consideration of clinical development for new anticancer drugs on Japan, proposal from approval reviewer].

PubMed

Urano, Tsutomu

2007-02-01

There become problems about a delay on clinical development of anticancer drug in Japan and drug lag. I consider causes and solutions of the problems from a position of drug approval reviewer. I think the drug lag may cause by stating later state in global clinical development or stagnation of clinical trial activities. To prevail against drug lag,it is necessary to attend to multinational clinical studies,and to mature Japanese clinical trial environment and post-market planning. Then, I believe that the most important point is to make a start on early stage of global clinical development.
Use of Subjective Global Assessment, Patient-Generated Subjective Global Assessment and Nutritional Risk Screening 2002 to evaluate the nutritional status of non-critically ill patients on parenteral nutrition.

PubMed

Badia-Tahull, M B; Cobo-Sacristán, S; Leiva-Badosa, E; Miquel-Zurita, M E; Méndez-Cabalerio, N; Jódar-Masanés, R; Llop-Talaverón, J

2014-02-01

To evaluate the nutritional status of non-critically ill digestive surgery patients at the moment of parenteral nutrition initiation using three different nutritional test tools and to study their correlation. To study the association between the tests and the clinical and laboratory parameters used in the follow-up of PN treatment. Prospective study over 4 months. Anthropometric and clinical variables were recorded. Results of Subjective Global Assessment; Patient-Generated Subjective Global Assessment; and Nutritional Risk Screening 2002 were compared applying kappa test. Relationship between the clinical and laboratory parameters with Subjective Global Assessment was studied by multinominal regression and with the other two tests by multiple linear regression models. Age and sex were included as adjustment variables. Malnutrition in 45 studied patients varied from 51% to 57%. Subjective Global Assessment correlated well with Patient-Generated Subjective Global Assessment and Nutritional Risk Screening 2002 (κ = 0531 p = 0.000). The test with the greatest correlation with the clinical and analytical variables was the Nutritional Risk Screening 2002. Worse nutritional state in this test was associated with worse results in albumin (B = -0.087; CI = -0.169/-0.005], prealbumin (B = -0.005; CI = [-0.011/-0.001]), C-reactive protein (B = 0.006;CI = [0.001/ 0.011]) and leukocytes (B = 0.134; CI = [0.031/0.237]) at the en of parenteral nutrition treatment. Half of the digestive surgery patients were at malnutritional risk at the moment of initiating parenteral nutrition. Nutritional Risk Screening 2002 was the test with best association with the parameters used in the clinical follow-up of parenteral nutrition treated patients. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.
Validating and determining the weight of items used for evaluating clinical governance implementation based on analytic hierarchy process model.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Vafaee Najar, Ali; Meraji, Marziye; Ebrahimipour, Hossein

2015-04-08

The purpose of implementing a system such as Clinical Governance (CG) is to integrate, establish and globalize distinct policies in order to improve quality through increasing professional knowledge and the accountability of healthcare professional toward providing clinical excellence. Since CG is related to change, and change requires money and time, CG implementation has to be focused on priority areas that are in more dire need of change. The purpose of the present study was to validate and determine the significance of items used for evaluating CG implementation. The present study was descriptive-quantitative in method and design. Items used for evaluating CG implementation were first validated by the Delphi method and then compared with one another and ranked based on the Analytical Hierarchy Process (AHP) model. The items that were validated for evaluating CG implementation in Iran include performance evaluation, training and development, personnel motivation, clinical audit, clinical effectiveness, risk management, resource allocation, policies and strategies, external audit, information system management, research and development, CG structure, implementation prerequisites, the management of patients' non-medical needs, complaints and patients' participation in the treatment process. The most important items based on their degree of significance were training and development, performance evaluation, and risk management. The least important items included the management of patients' non-medical needs, patients' participation in the treatment process and research and development. The fundamental requirements of CG implementation included having an effective policy at national level, avoiding perfectionism, using the expertise and potentials of the entire country and the coordination of this model with other models of quality improvement such as accreditation and patient safety. © 2015 by Kerman University of Medical Sciences.
Looking for the Perfect Mentor.

PubMed

Sá, Ana Pinheiro; Teixeira-Pinto, Cristina; Veríssimo, Rafaela; Vilas-Boas, Andreia; Firmino-Machado, João

2015-01-01

The authors established the profile of the Internal Medicine clinical teachers in Portugal aiming to define a future interventional strategy plan as adequate as possible to the target group and to the problems identified by the residents. Observational, transversal, analytic study. An online anonymous questionnaire was defined, evaluating the demographic characteristics of the clinical teachers, their path in Internal Medicine and their involvement in the residents learning process. We collected 213 valid questionnaires, making for an estimated response rate of 28.4%. Median global satisfaction with the clinical teacher was 4.52 (± 1.33 points) and the classification of the relationship between resident and clinical teacher was 4.86 ± 1.04 points. The perfect clinical teacher is defined by high standards of dedication and responsibility (4.9 ± 1.37 points), practical (4.8 ± 1.12 points) and theoretical skills (4.8 ± 1.07 points). The multiple linear regression model allowed to determine predictors of the residentâs satisfaction with their clinical teacher, justifying 82,5% of the variation of satisfaction with the clinical teacher (R2 = 0.83; R2 a = 0.82). Postgraduate medical education consists of an interaction between several areas of knowledge and intervening variables in the learning process having the clinical teacher in the central role. Overall, the pedagogical abilities were the most valued by the Internal Medicine residents regarding their clinical teacher, as determinants of a quality residentship. This study demonstrates the critical relevance of the clinical teacher in the satisfaction of residents with their residentship. The established multiple linear regression model highlights the impact of the clinical and pedagogical relantionship with the clinical teacher in a relevant increase in the satisfaction with the latter.
The use of Animal-Assisted Therapy in adolescents with acute mental disorders: A randomized controlled study.

PubMed

Stefanini, M C; Martino, A; Allori, P; Galeotti, F; Tani, F

2015-02-01

The aim of this study was to compare the effects of Animal-Assisted Therapy (AAT) with a standard treatment protocol in children and adolescents admitted to the psychiatry hospital for acute mental disorders. We used a methodology involving high quality standards for AAT research. A pre-post experimental design with a randomized controlled trial (RCT) in 34 hospitalized patients (17 treatment, 17 control) was carried out. The study focused on improvement in clinical status including, global functioning measured by the Children Global Assessment Scale (C GAS), format of care and ordinary school attendance measured by a rating scale. Our results indicate a statistically significant improvement in global functioning, reduction in format of care and increased ordinary school attendance in the treatment group, but not in the control group. Our results verify that AAT can have significant positive effects on therapeutic progress and the recovery process. Copyright © 2015 Elsevier Ltd. All rights reserved.
A global goodness-of-fit statistic for Cox regression models.

PubMed

Parzen, M; Lipsitz, S R

1999-06-01

In this paper, a global goodness-of-fit test statistic for a Cox regression model, which has an approximate chi-squared distribution when the model has been correctly specified, is proposed. Our goodness-of-fit statistic is global and has power to detect if interactions or higher order powers of covariates in the model are needed. The proposed statistic is similar to the Hosmer and Lemeshow (1980, Communications in Statistics A10, 1043-1069) goodness-of-fit statistic for binary data as well as Schoenfeld's (1980, Biometrika 67, 145-153) statistic for the Cox model. The methods are illustrated using data from a Mayo Clinic trial in primary billiary cirrhosis of the liver (Fleming and Harrington, 1991, Counting Processes and Survival Analysis), in which the outcome is the time until liver transplantation or death. The are 17 possible covariates. Two Cox proportional hazards models are fit to the data, and the proposed goodness-of-fit statistic is applied to the fitted models.
A new test for the assessment of working memory in clinical settings: Validation and norming of a month ordering task.

PubMed

Buekenhout, Imke; Leitão, José; Gomes, Ana A

2018-05-24

Month ordering tasks have been used in experimental settings to obtain measures of working memory (WM) capacity in older/clinical groups based solely on their face validity. We sought to assess the appropriateness of using a month ordering task in other contexts, including clinical settings, as a psychometrically sound WM assessment. To this end, we constructed a month ordering task (ucMOT), studied its reliability (internal consistency and temporal stability), and gathered construct-related and criterion-related validity evidence for its use as a WM assessment. The ucMOT proved to be internally consistent and temporally stable, and analyses of the criterion-related validity evidence revealed that its scores predicted the efficiency of language comprehension processes known to depend crucially on WM resources, namely, processes involved in pronoun interpretation. Furthermore, all ucMOT items discriminated between younger and older age groups; the global scores were significantly correlated with scores on well-established WM tasks and presented lower correlations with instruments that evaluate different (although related) processes, namely, inhibition and processing speed. We conclude that the ucMOT possesses solid psychometric properties. Accordingly, we acquired normative data for the Portuguese population, which we present as a regression-based algorithm that yields z scores adjusted for age, gender, and years of formal education. (PsycINFO Database Record (c) 2018 APA, all rights reserved).
[Clinical drug trials in Germany--an assessment of current status from the viewpoint of industry].

PubMed

Baumbauer, E

1996-01-01

Drug development today is a highly professional and costly affair, whereby quality and speed are decisive competitive factors in a global setting. Germany is in the process of losing its attractiveness for clinical drug research as evidenced by a significant decrease in funding of clinical drug research which at the moment amounts to about 1.5 billion DM/year. This decrease is due to an adverse environment created by a certain anxiety in public opinion regarding technological advances, an overburden of regulations, lack of an infrastructure in hospitals to work according to GCP and a regulatory agency which has to compete with momentarily more effective agencies in Europe (UK, France). A joint effort between industry and the medical profession is called for to change this situation for the better.
Global mental health and the National Institute of Mental Health Research Domain Criteria.

PubMed

Weine, Stevan Merill; Langenecker, Scott; Arenliu, Aliriza

2018-05-01

The National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) project presents innovative ways of investigating mental illness based on behavioral and neurobiological measures of dimensional processes. Although cultural psychiatrists have critiqued RDoC's implications and limitations for its under-developed focus on context and experience, RDoC presents opportunities for synergies with global mental health. It can capture aspects of clinical or sub-clinical behavior which are less dependent upon Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) and perhaps better elucidate the role of culture in disease expression and resilience. Aim/Results: This article uses the example of migration to describe several starting points for new research: (1) providing components for building an investigable conceptual framework to understand individual's mental health, resilience and adjustment to migration challenges or social adversities in low- and middle-income countries (LMICs) and (2) identifying measurable factors which determine resilience or vulnerability, to guide development and evaluation of targeted prevention, treatment and recovery strategies for mental health in LMICs. In such ways, RDoC frameworks could help put the new cutting edge neurobiological dimensional scientific advances in a position to contribute to addressing mental health problems amid social adversities in LMICs. However, this would require a much-expanded commitment by both RDoC and global mental health researchers to address contextual and experiential dimensions.
Clinical reasoning of Filipino physical therapists: Experiences in a developing nation.

PubMed

Rotor, Esmerita R; Capio, Catherine M

2018-03-01

Clinical reasoning is essential for physical therapists to engage in the process of client care, and has been known to contribute to professional development. The literature on clinical reasoning and experiences have been based on studies from Western and developed nations, from which multiple influencing factors have been found. A developing nation, the Philippines, has distinct social, economic, political, and cultural circumstances. Using a phenomenological approach, this study explored experiences of Filipino physical therapists on clinical reasoning. Ten therapists working in three settings: 1) hospital; 2) outpatient clinic; and 3) home health were interviewed. Major findings were: a prescription-based referral system limited clinical reasoning; procedural reasoning was a commonly experienced strategy while diagnostic and predictive reasoning were limited; factors that influenced clinical reasoning included practice setting and the professional relationship with the referring physician. Physical therapists' responses suggested a lack of autonomy in practice that appeared to stifle clinical reasoning. Based on our findings, we recommend that the current regulations governing PT practice in the Philippines may be updated, and encourage educators to strengthen teaching approaches and strategies that support clinical reasoning. These recommendations are consistent with the global trend toward autonomous practice.
The quest to standardize hemodialysis care.

PubMed

Hegbrant, Jörgen; Gentile, Giorgio; Strippoli, Giovanni F M

2011-01-01

A large global dialysis provider's core activities include providing dialysis care with excellent quality, ensuring a low variability across the clinic network and ensuring strong focus on patient safety. In this article, we summarize the pertinent components of the quality assurance and safety program of the Diaverum Renal Services Group. Concerning medical performance, the key components of a successful quality program are setting treatment targets; implementing evidence-based guidelines and clinical protocols; consistently, regularly, prospectively and accurately collecting data from all clinics in the network; processing collected data to provide feedback to clinics in a timely manner, incorporating information on interclinic and intercountry variations; and revising targets, guidelines and clinical protocols based on sound scientific data. The key activities for ensuring patient safety include a standardized approach to education, i.e. a uniform education program including control of theoretical knowledge and clinical competencies; implementation of clinical policies and procedures in the organization in order to reduce variability and potential defects in clinic practice; and auditing of clinical practice on a regular basis. By applying a standardized and systematic continuous quality improvement approach throughout the entire organization, it has been possible for Diaverum to progressively improve medical performance and ensure patient safety. Copyright © 2011 S. Karger AG, Basel.
Psilocybin impairs high-level but not low-level motion perception.

PubMed

Carter, Olivia L; Pettigrew, John D; Burr, David C; Alais, David; Hasler, Felix; Vollenweider, Franz X

2004-08-26

The hallucinogenic serotonin(1A&2A) agonist psilocybin is known for its ability to induce illusions of motion in otherwise stationary objects or textured surfaces. This study investigated the effect of psilocybin on local and global motion processing in nine human volunteers. Using a forced choice direction of motion discrimination task we show that psilocybin selectively impairs coherence sensitivity for random dot patterns, likely mediated by high-level global motion detectors, but not contrast sensitivity for drifting gratings, believed to be mediated by low-level detectors. These results are in line with those observed within schizophrenic populations and are discussed in respect to the proposition that psilocybin may provide a model to investigate clinical psychosis and the pharmacological underpinnings of visual perception in normal populations.
Validity of prototype diagnosis for mood and anxiety disorders.

PubMed

DeFife, Jared A; Peart, Joanne; Bradley, Bekh; Ressler, Kerry; Drill, Rebecca; Westen, Drew

2013-02-01

CONTEXT With growing recognition that most forms of psychopathology are best represented as dimensions or spectra, a central question becomes how to implement dimensional diagnosis in a way that is empirically sound and clinically useful. Prototype matching, which involves comparing a patient's clinical presentation with a prototypical description of the disorder, is an approach to diagnosis that has gained increasing attention with forthcoming revisions to both the DSM and the International Classification of Diseases. OBJECTIVE To examine prototype diagnosis for mood and anxiety disorders. DESIGN, SETTING, AND PATIENTS In the first study, we examined clinicians' DSM-IV and prototype diagnoses with their ratings of the patients' adaptive functioning and patients' self-reported symptoms. In the second study, independent interviewers made prototype diagnoses following either a systematic clinical interview or a structured diagnostic interview. A third interviewer provided independent ratings of global adaptive functioning. Patients were recruited as outpatients (study 1; N = 84) and from primary care clinics (study 2; N = 143). MAIN OUTCOME MEASURES Patients' self-reported mood, anxiety, and externalizing symptoms along with independent clinical ratings of adaptive functioning. RESULTS Clinicians' prototype diagnoses showed small to moderate correlations with patient-reported psychopathology and performed as well as or better than DSM-IV diagnoses. Prototype diagnoses from independent interviewers correlated on average r = .50 and showed substantial incremental validity over DSM-IV diagnoses in predicting adaptive functioning. CONCLUSIONS Prototype matching is a viable alternative for psychiatric diagnosis. As in research on personality disorders, mood and anxiety disorder prototypes outperformed DSM-IV decision rules in predicting psychopathology and global functioning. Prototype matching has multiple advantages, including ease of use in clinical practice, reduced artifactual comorbidity, compatibility with naturally occurring cognitive processes in diagnosticians, and ready translation into both categorical and dimensional diagnosis.
Clinical Decision Making in the Management of Patients With Cervicogenic Dizziness: A Case Series.

PubMed

Jung, Francis C; Mathew, Sherin; Littmann, Andrew E; MacDonald, Cameron W

2017-11-01

Study Design Case series. Background Although growing recognition of cervicogenic dizziness (CGD) is emerging, there is still no gold standard for the diagnosis of CGD. The purpose of this case series is to describe the clinical decision making utilized in the management of 7 patients presenting with CGD. Case Description Patients presenting with neck pain and accompanying subjective symptoms, including dizziness, unsteadiness, light-headedness, and visual disturbance, were selected. Clinical evidence of a temporal relationship between neck pain and dizziness, with or without sensorimotor disturbances, was assessed. Clinical decision making followed a 4-step process, informed by the current available best evidence. Outcome measures included the numeric rating scale for dizziness and neck pain, the Dizziness Handicap Inventory, Patient-Specific Functional Scale, and global rating of change. Outcomes Seven patients (mean age, 57 years; range, 31-86 years; 7 female) completed physical therapy management at an average of 13 sessions (range, 8-30 sessions) over a mean of 7 weeks. Clinically meaningful improvements were observed in the numeric rating scale for dizziness (mean difference, 5.7; 95% confidence interval [CI]: 4.0, 7.5), neck pain (mean difference, 5.4; 95% CI: 3.8, 7.1), and the Dizziness Handicap Inventory (mean difference, 32.6; 95% CI: 12.9, 52.2) at discontinuation. Patients also demonstrated overall satisfaction via the Patient-Specific Functional Scale (mean difference, 9) and global rating of change (mean, +6). Discussion This case series describes the physical therapist decision making, management, and outcomes in patients with CGD. Further investigation is warranted to develop a valid clinical decision-making guideline to inform management of patients with CGD. Level of Evidence Diagnosis, therapy, level 4. J Orthop Sports Phys Ther 2017;47(11):874-884. Epub 9 Oct 2017. doi:10.2519/jospt.2017.7425.
Perception of shapes targeting local and global processes in autism spectrum disorders.

PubMed

Grinter, Emma J; Maybery, Murray T; Pellicano, Elizabeth; Badcock, Johanna C; Badcock, David R

2010-06-01

Several researchers have found evidence for impaired global processing in the dorsal visual stream in individuals with autism spectrum disorders (ASDs). However, support for a similar pattern of visual processing in the ventral visual stream is less consistent. Critical to resolving the inconsistency is the assessment of local and global form processing ability. Within the visual domain, radial frequency (RF) patterns - shapes formed by sinusoidally varying the radius of a circle to add 'bumps' of a certain number to a circle - can be used to examine local and global form perception. Typically developing children and children with an ASD discriminated between circles and RF patterns that are processed either locally (RF24) or globally (RF3). Children with an ASD required greater shape deformation to identify RF3 shapes compared to typically developing children, consistent with difficulty in global processing in the ventral stream. No group difference was observed for RF24 shapes, suggesting intact local ventral-stream processing. These outcomes support the position that a deficit in global visual processing is present in ASDs, consistent with the notion of Weak Central Coherence.
Correlation of neurocognitive function and brain lesion load on magnetic resonance imaging in systemic lupus erythematosus.

PubMed

Roldan, Paola C; Jung, Rex E; Sibbitt, Wilmer L; Qualls, Clifford R; Flores, Ranee A; Roldan, Carlos A

2018-06-13

Neurocognitive dysfunction and brain injury on magnetic resonance imaging (MRI) are common in patients with systemic lupus erythematosus (SLE) and are associated with increased morbidity and mortality. However, brain MRI is expensive, is restricted by payers, and requires high expertise. Neurocognitive assessment is an easily available, safe, and inexpensive clinical tool that may select patients needing brain MRI. In this cross-sectional and controlled study, 76 SLE patients (69 women, age 37 ± 12 years) and 26 age and gender-matched healthy subjects (22 women, age 34 ± 11 years) underwent assessment of attention, memory, processing speed, executive function, motor function, and global neurocognitive function. All subjects underwent brain MRI with T1-weighted, fluid-attenuated inversion recovery (FLAIR), and diffusion-weighted imaging. Hemispheric and whole brain lesion load in cm 3 were determined using semi-automated methods. Neurocognitive z-scores in all clinical domains were significantly lower and whole brain and right and left hemispheres brain lesion load were significantly greater in patients than in controls (all p ≤ 0.02). There was significant correlation between neurocognitive z-scores in all domains and whole brain lesion load: processing speed (r = - 0.46; p < 0.0001), attention (r = - 0.42; p < 0.001), memory (r = - 0.40; p = 0.0004), executive function (r = - 0.25; p = 0.03), motor function (r = - 0.25; p = 0.05), and global neurocognitive function (r = - 0.38; p = 0.006). Similar correlations were found for brain hemisphere lesion loads (all p ≤ 0.05). These correlations were strengthened when adjusted for glucocorticoid therapy and SLE disease activity index. Finally, global neurocognitive z-score and erythrosedimentation rate were the only independent predictors of whole brain lesion load (both p ≤ 0.007). Neurocognitive measures and brain lesion load are worse in SLE patients than in controls. In SLE patients, neurocognitive z-scores correlate negatively with and independently predict brain lesion load. Therefore, neurocognitive testing may be an effective clinical tool to select patients needing brain MRI.
Linking international research to global health equity: the limited contribution of bioethics.

PubMed

Pratt, Bridget; Loff, Bebe

2013-05-01

Health research has been identified as a vehicle for advancing global justice in health. However, in bioethics, issues of global justice are mainly discussed within an ongoing debate on the conditions under which international clinical research is permissible. As a result, current ethical guidance predominantly links one type of international research (biomedical) to advancing one aspect of health equity (access to new treatments). International guidelines largely fail to connect international research to promoting broader aspects of health equity - namely, healthier social environments and stronger health systems. Bioethical frameworks such as the human development approach do consider how international clinical research is connected to the social determinants of health but, again, do so to address the question of when international clinical research is permissible. It is suggested that the narrow focus of this debate is shaped by high-income countries' economic strategies. The article further argues that the debate's focus obscures a stronger imperative to consider how other types of international research might advance justice in global health. Bioethics should consider the need for non-clinical health research and its contribution to advancing global justice. © 2011 Blackwell Publishing Ltd.
Global-local processing relates to spatial and verbal processing: implications for sex differences in cognition.

PubMed

Pletzer, Belinda; Scheuringer, Andrea; Scherndl, Thomas

2017-09-05

Sex differences have been reported for a variety of cognitive tasks and related to the use of different cognitive processing styles in men and women. It was recently argued that these processing styles share some characteristics across tasks, i.e. male approaches are oriented towards holistic stimulus aspects and female approaches are oriented towards stimulus details. In that respect, sex-dependent cognitive processing styles share similarities with attentional global-local processing. A direct relationship between cognitive processing and global-local processing has however not been previously established. In the present study, 49 men and 44 women completed a Navon paradigm and a Kimchi Palmer task as well as a navigation task and a verbal fluency task with the goal to relate the global advantage (GA) effect as a measure of global processing to holistic processing styles in both tasks. Indeed participants with larger GA effects displayed more holistic processing during spatial navigation and phonemic fluency. However, the relationship to cognitive processing styles was modulated by the specific condition of the Navon paradigm, as well as the sex of participants. Thus, different types of global-local processing play different roles for cognitive processing in men and women.
Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.

PubMed

Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie

2017-06-01

The Food and Drug Administration's final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative-nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. The investigative site's responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors'"filtering" of reports and increased sponsor communication. Sponsors replied that their greatest challenges include (1) lack of global harmonization in reporting rules, (2) determining causality, and (3) fear of regulatory repercussions. Interaction with the Food and Drug Administration has helped improve sponsors' adherence to the final rule, and sponsors would benefit from increased communication with the Food and Drug Administration and educational materials. The goal of the final rule is to minimize uninformative safety reports so that important safety signals can be captured and communicated early enough in a clinical program to make changes that help ensure patient safety. Investigative staff and sponsors acknowledge that the rule has not been fully implemented although they agree with the intention. Clinical Trials Transformation Initiative will use the results from the surveys and interviews to develop new recommendations and educational materials that will be available to sponsors to increase compliance with the final rule and facilitate discussion between sponsors, investigators, and Food and Drug Administration representatives.
Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

PubMed Central

Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie

2017-01-01

Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of reports and increased sponsor communication. Sponsors replied that their greatest challenges include (1) lack of global harmonization in reporting rules, (2) determining causality, and (3) fear of regulatory repercussions. Interaction with the Food and Drug Administration has helped improve sponsors’ adherence to the final rule, and sponsors would benefit from increased communication with the Food and Drug Administration and educational materials. Conclusion: The goal of the final rule is to minimize uninformative safety reports so that important safety signals can be captured and communicated early enough in a clinical program to make changes that help ensure patient safety. Investigative staff and sponsors acknowledge that the rule has not been fully implemented although they agree with the intention. Clinical Trials Transformation Initiative will use the results from the surveys and interviews to develop new recommendations and educational materials that will be available to sponsors to increase compliance with the final rule and facilitate discussion between sponsors, investigators, and Food and Drug Administration representatives. PMID:28345368

Auditory global-local processing: effects of attention and musical experience.

PubMed

Ouimet, Tia; Foster, Nicholas E V; Hyde, Krista L

2012-10-01

In vision, global (whole) features are typically processed before local (detail) features ("global precedence effect"). However, the distinction between global and local processing is less clear in the auditory domain. The aims of the present study were to investigate: (i) the effects of directed versus divided attention, and (ii) the effect musical training on auditory global-local processing in 16 adult musicians and 16 non-musicians. Participants were presented with short nine-tone melodies, each comprised of three triplet sequences (three-tone units). In a "directed attention" task, participants were asked to focus on either the global or local pitch pattern and had to determine if the pitch pattern went up or down. In a "divided attention" task, participants judged whether the target pattern (up or down) was present or absent. Overall, global structure was perceived faster and more accurately than local structure. The global precedence effect was observed regardless of whether attention was directed to a specific level or divided between levels. Musicians performed more accurately than non-musicians overall, but non-musicians showed a more pronounced global advantage. This study provides evidence for an auditory global precedence effect across attention tasks, and for differences in auditory global-local processing associated with musical experience.
Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial.

PubMed

Harris, Deborah L; Alsweiler, Jane M; Ansell, Judith M; Gamble, Gregory D; Thompson, Benjamin; Wouldes, Trecia A; Yu, Tzu-Ying; Harding, Jane E

2016-03-01

To determine neurodevelopmental outcome at 2 years' corrected age in children randomized to treatment with dextrose gel or placebo for hypoglycemia soon after birth (The Sugar Babies Study). This was a follow-up study of 184 children with hypoglycemia (<2.6 mM [47 mg/dL]) in the first 48 hours and randomized to either dextrose (90/118, 76%) or placebo gel (94/119, 79%). Assessments were performed at Kahikatea House, Hamilton, New Zealand, and included neurologic function and general health (pediatrician assessed), cognitive, language, behavior, and motor skills (Bayley Scales of Infant and Toddler Development, Third Edition), executive function (clinical assessment and Behaviour Rating Inventory of Executive Function-Preschool Edition), and vision (clinical examination and global motion perception). Coprimary outcomes were neurosensory impairment (cognitive, language or motor score below -1 SD or cerebral palsy or blind or deaf) and processing difficulty (executive function or global motion perception worse than 1.5 SD from the mean). Statistical tests were two sided with 5% significance level. Mean (± SD) birth weight was 3093 ± 803 g and mean gestation was 37.7 ± 1.6 weeks. Sixty-six children (36%) had neurosensory impairment (1 severe, 6 moderate, 59 mild) with similar rates in both groups (dextrose 38% vs placebo 34%, relative risk 1.11, 95% CI 0.75-1.63). Processing difficulty also was similar between groups (dextrose 10% vs placebo 18%, relative risk 0.52, 95% CI 0.23-1.15). Dextrose gel is safe for the treatment of neonatal hypoglycemia, but neurosensory impairment is common among these children. Australian New Zealand Clinical Trials Registry: ACTRN 12608000623392. Copyright © 2016 Elsevier Inc. All rights reserved.
Global ablation techniques.

PubMed

Woods, Sarah; Taylor, Betsy

2013-12-01

Global endometrial ablation techniques are a relatively new surgical technology for the treatment of heavy menstrual bleeding that can now be used even in an outpatient clinic setting. A comparison of global ablation versus earlier ablation technologies notes no significant differences in success rates and some improvement in patient satisfaction. The advantages of the newer global endometrial ablation systems include less operative time, improved recovery time, and decreased anesthetic risk. Ablation procedures performed in an outpatient surgical or clinic setting provide advantages both of potential cost savings for patients and the health care system and improved patient convenience. Copyright © 2013. Published by Elsevier Inc.
Global cardiovascular device innovation: Japan-USA synergies: Harmonization by Doing (HBD) program, a consortium of regulatory agencies, medical device industry, and academic institutions.

PubMed

Uchida, Takahiro; Ikeno, Fumiaki; Ikeda, Koji; Suzuki, Yuka; Todaka, Koji; Yokoi, Hiroyoshi; Thompson, Gary; Krucoff, Mitchel; Saito, Shigeru

2013-01-01

Global medical devices have become more popular, but investment money for medical device development is not easily available in the market. Worldwide health-care budget constraints mean that efficient medical device development has become essential. To achieve efficient development, globalization is a key to success. Spending large amounts of money in different regions for medical device development is no longer feasible. In order to streamline processes of global medical device development, an academic, governmental, and industrial consortium, called the Harmonization by Doing program, has been set up. The program has been operating between Japan and the USA since 2003. The program has 4 working groups: (1) Global Cardiovascular Device Trials; (2) Study on Post-Market Registry; (3) Clinical Trials; and (4) Infrastructure and Methodology Regulatory Convergence and Communication. Each working group has as its goals the achievement of speedy and efficient medical device development in Japan and the USA. The program has held multiple international meetings to deal with obstacles against efficient medical device development. This kind of program is very important to deliver novel medical devices. Involvement of physicians in this type of activity is also very helpful to achieve these goals.
A methodology for successfully producing global translations of patient reported outcome measures for use in multiple countries.

PubMed

Two, Rebecca; Verjee-Lorenz, Aneesa; Clayson, Darren; Dalal, Mehul; Grotzinger, Kelly; Younossi, Zobair M

2010-01-01

The production of accurate and culturally relevant translations of patient reported outcome (PRO) measures is essential for the success of international clinical trials. Although there are many reports in publication regarding the translation of PRO measures, the techniques used to produce single translations for use in multiple countries (global translations) are not well documented. This article addresses this apparent lack of documentation and presents the methodology used to create global translations of the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV). The challenges of creating a translation for use in multiple countries are discussed, and the criteria for a global translation project explained. Based on a thorough translation and linguistic validation methodology including a concept elaboration, multiple forward translations, two back translations, reviews by in-country clinicians and the instrument developer, pilot testing in each target country and multiple sets of proofreading, the key concept of the global translation methodology is consistent international harmonization, achieved through the involvement of linguists from each target country at every stage of the process. This methodology enabled the successful resolution of the translation issues encountered, and resulted in consistent translations of the CLDQ-HCV that were linguistically and culturally appropriate for all target countries.
Climate change and skin.

PubMed

Balato, N; Ayala, F; Megna, M; Balato, A; Patruno, C

2013-02-01

Global climate appears to be changing at an unprecedented rate. Climate change can be caused by several factors that include variations in solar radiation received by earth, oceanic processes (such as oceanic circulation), plate tectonics, and volcanic eruptions, as well as human-induced alterations of the natural world. Many human activities, such as the use of fossil fuel and the consequent accumulation of greenhouse gases in the atmosphere, land consumption, deforestation, industrial processes, as well as some agriculture practices are contributing to global climate change. Indeed, many authors have reported on the current trend towards global warming (average surface temperature has augmented by 0.6 °C over the past 100 years), decreased precipitation, atmospheric humidity changes, and global rise in extreme climatic events. The magnitude and cause of these changes and their impact on human activity have become important matters of debate worldwide, representing climate change as one of the greatest challenges of the modern age. Although many articles have been written based on observations and various predictive models of how climate change could affect social, economic and health systems, only few studies exist about the effects of this change on skin physiology and diseases. However, the skin is the most exposed organ to environment; therefore, cutaneous diseases are inclined to have a high sensitivity to climate. For example, global warming, deforestation and changes in precipitation have been linked to variations in the geographical distribution of vectors of some infectious diseases (leishmaniasis, lyme disease, etc) by changing their spread, whereas warm and humid environment can also encourage the colonization of the skin by bacteria and fungi. The present review focuses on the wide and complex relationship between climate change and dermatology, showing the numerous factors that are contributing to modify the incidence and the clinical pattern of many dermatoses.
The globalization of football: a study in the glocalization of the 'serious life'.

PubMed

Giulianotti, Richard; Robertson, Roland

2004-12-01

Sport, in particular football, constitutes one of the most dynamic, sociologically illuminating domains of globalization. This paper examines the globalization of football with particular reference to Robertson's theorizations of global processes. We examine football's cultural globalization through the concept of 'glocalization', which highlights the interdependence of local and global processes within the game's identities and institutions. We address economic globalization in football by considering the world's leading clubs as 'glocal' transnational corporations. We assess the political globalization of football with reference to the possible enhancement of democracy within the game's international governance. We conclude by affirming the utility of sport in advancing our empirical and theoretical understanding of globalization processes.
Genomic Methods for Clinical and Translational Pain Research

PubMed Central

Wang, Dan; Kim, Hyungsuk; Wang, Xiao-Min; Dionne, Raymond

2012-01-01

Pain is a complex sensory experience for which the molecular mechanisms are yet to be fully elucidated. Individual differences in pain sensitivity are mediated by a complex network of multiple gene polymorphisms, physiological and psychological processes, and environmental factors. Here, we present the methods for applying unbiased molecular-genetic approaches, genome-wide association study (GWAS), and global gene expression analysis, to help better understand the molecular basis of pain sensitivity in humans and variable responses to analgesic drugs. PMID:22351080
KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors

PubMed Central

Lentine, Krista L.; Kasiske, Bertram L.; Levey, Andrew S.; Adams, Patricia L.; Alberú, Josefina; Bakr, Mohamed A.; Gallon, Lorenzo; Garvey, Catherine A.; Guleria, Sandeep; Li, Philip Kam-Tao; Segev, Dorry L.; Taler, Sandra J.; Tanabe, Kazunari; Wright, Linda; Zeier, Martin G.; Cheung, Michael; Garg, Amit X.

2017-01-01

Abstract The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant studies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive approach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses were undertaken to produce a “proof-in-concept” risk-prediction model for kidney failure to support a framework for quantitative risk assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the simultaneous consideration of each candidate's profile of demographic and health characteristics. The processes and framework for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk prediction and novel approaches to estimating donation-attributable risks, are also provided. In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017;101(Suppl 8S):S1–S109. PMID:28742762
The competency of internists in holistic global care to support healthy Indonesia 2010.

PubMed

Rudijanto, Achmad

2006-01-01

All patients are entitled to good standards of practice and care from their doctors. The improved health of all peoples is the main goal of medical education, including for the education of internal medicine registrars. The future development of the direction and goal of education, the level of competence of internal medicine specialists, and the process of learning will be related to preparing the internal medicine specialist to have global competitive advantage. Identification of general competencies is the first step in a long-term effort designed to emphasize educational outcome, for assessment in residency programs, and in the accreditation process. To achieve that competence, a variety of learning opportunities need to be provided in order that the resident can achieve the necessary knowledge, skills, attitude, and behaviors. Identification of the role and function of internal medicine specialists is needed prior to the development of the general competencies. As educational objectives, the competencies fall into two main categories: knowledge-based and performance-based. Knowledge-based competency has two components, medical knowledge (bio-science and clinical medicine) and contextual knowledge (epidemiology, health service organization, and human behavior). The performance base has two components, intellectual skills and the interpersonal skills. Besides the two main categories of educational objectives, there are behavioral objectives that residents must achieve through the educational program, to ensure that residents are able to deal with a range of prescribed clinical situations effectively, safely, humanely, and economically. The achievement of behavioral objectives will ensure, at least in part, that the doctor will implement good medical practice. The index clinical/community situations (ICS) on which the educational objectives will be based are taken from diseases and illnesses that occur in clinical and community settings. No resident can master all medicine there is to know, as there are no limits to what can be known about medicine. It is important to make choices in selecting what residents should learn by analyzing the ICS.
Using the Donabedian framework to examine the quality and safety of nursing service innovation.

PubMed

Gardner, Glenn; Gardner, Anne; O'Connell, Jane

2014-01-01

To evaluate the safety and quality of nurse practitioner service using the audit framework of Structure, Process and Outcome. Health service and workforce reform are on the agenda of governments and other service providers seeking to contain healthcare costs whilst providing safe and effective health care to communities. The nurse practitioner service is one health workforce innovation that has been adopted globally to improve timely access to clinical care, but there is scant literature reporting evaluation of the quality of this service innovation. A mixed-methods design within the Donabedian evaluation framework was used. The Donabedian framework was used to evaluate the Structure, Process and Outcome of nurse practitioner service. A range of data collection approaches was used, including stakeholder survey (n = 36), in-depth interviews (11 patients and 13 nurse practitioners) and health records data on service processes. The study identified that adequate and detailed preparation of Structure and Process is essential for the successful implementation of a service innovation. The multidisciplinary team was accepting of the addition of nurse practitioner service, and nurse practitioner clinical care was shown to be effective, satisfactory and safe from the perspective of the clinician stakeholders and patients. This study demonstrated that the Donabedian framework of Structure, Process and Outcome evaluation is a valuable and validated approach to examine the safety and quality of a service innovation. Furthermore, in this study, specific Structure elements were shown to influence the quality of service processes further validating the framework and the interdependence of the Structure, Process and Outcome components. Understanding the Structure and Process requirements for establishing nursing service innovation lays the foundation for safe, effective and patient-centred clinical care. © 2013 John Wiley & Sons Ltd.
Quality assurance of radiotherapy in cancer treatment: toward improvement of patient safety and quality of care.

PubMed

Ishikura, Satoshi

2008-11-01

The process of radiotherapy (RT) is complex and involves understanding of the principles of medical physics, radiobiology, radiation safety, dosimetry, radiation treatment planning, simulation and interaction of radiation with other treatment modalities. Each step in the integrated process of RT needs quality control and quality assurance (QA) to prevent errors and to give high confidence that patients will receive the prescribed treatment correctly. Recent advances in RT, including intensity-modulated and image-guided RT, focus on the need for a systematic RTQA program that balances patient safety and quality with available resources. It is necessary to develop more formal error mitigation and process analysis methods, such as failure mode and effect analysis, to focus available QA resources optimally on process components. External audit programs are also effective. The International Atomic Energy Agency has operated both an on-site and off-site postal dosimetry audit to improve practice and to assure the dose from RT equipment. Several countries have adopted a similar approach for national clinical auditing. In addition, clinical trial QA has a significant role in enhancing the quality of care. The Advanced Technology Consortium has pioneered the development of an infrastructure and QA method for advanced technology clinical trials, including credentialing and individual case review. These activities have an impact not only on the treatment received by patients enrolled in clinical trials, but also on the quality of treatment administered to all patients treated in each institution, and have been adopted globally; by the USA, Europe and Japan also.
Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

PubMed

Asano, K; Tanaka, A; Sato, T; Uyama, Y

2013-08-01

Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.
Sequential processing deficits in schizophrenia: relationship to neuropsychology and genetics.

PubMed

Hill, S Kristian; Bjorkquist, Olivia; Carrathers, Tarra; Roseberry, Jarett E; Hochberger, William C; Bishop, Jeffrey R

2013-12-01

Utilizing a combination of neuropsychological and cognitive neuroscience approaches may be essential for characterizing cognitive deficits in schizophrenia and eventually assessing cognitive outcomes. This study was designed to compare the stability of select exemplars for these approaches and their correlations in schizophrenia patients with stable treatment and clinical profiles. Reliability estimates for serial order processing were comparable to neuropsychological measures and indicate that experimental serial order processing measures may be less susceptible to practice effects than traditional neuropsychological measures. Correlations were moderate and consistent with a global cognitive factor. Exploratory analyses indicated a potentially critical role of the Met allele of the Catechol-O-methyltransferase (COMT) Val158Met polymorphism in externally paced sequential recall. Experimental measures of serial order processing may reflect frontostriatal dysfunction and be a useful supplement to large neuropsychological batteries. © 2013.
Sequential Processing Deficits in Schizophrenia: Relationship to Neuropsychology and Genetics

PubMed Central

Hill, S. Kristian; Bjorkquist, Olivia; Carrathers, Tarra; Roseberry, Jarett E.; Hochberger, William C.; Bishop, Jeffrey R.

2014-01-01

Utilizing a combination of neuropsychological and cognitive neuroscience approaches may be essential for characterizing cognitive deficits in schizophrenia and eventually assessing cognitive outcomes. This study was designed to compare the stability of select exemplars for these approaches and their correlations in schizophrenia patients with stable treatment and clinical profiles. Reliability estimates for serial order processing were comparable to neuropsychological measures and indicate that experimental serial order processing measures may be less susceptible to practice effects than traditional neuropsychological measures. Correlations were moderate and consistent with a global cognitive factor. Exploratory analyses indicated a potentially critical role of the Met allele of the Catechol-O-methyltransferase (COMT) Val158Met polymorphism in externally paced sequential recall. Experimental measures of serial order processing may reflect frontostriatal dysfunction and be a useful supplement to large neuropsychological batteries. PMID:24119464
Evolving trends in mAb production processes

PubMed Central

Wolfe, Leslie S.; Mostafa, Sigma S.; Norman, Carnley

2017-01-01

Abstract Monoclonal antibodies (mAbs) have established themselves as the leading biopharmaceutical therapeutic modality. The establishment of robust manufacturing platforms are key for antibody drug discovery efforts to seamlessly translate into clinical and commercial successes. Several drivers are influencing the design of mAb manufacturing processes. The advent of biosimilars is driving a desire to achieve lower cost of goods and globalize biologics manufacturing. High titers are now routinely achieved for mAbs in mammalian cell culture. These drivers have resulted in significant evolution in process platform approaches. Additionally, several new trends in bioprocessing have arisen in keeping with these needs. These include the consideration of alternative expression systems, continuous biomanufacturing and non‐chromatographic separation formats. This paper discusses these drivers in the context of the kinds of changes they are driving in mAb production processes. PMID:29313024
Clinical microbiology informatics.

PubMed

Rhoads, Daniel D; Sintchenko, Vitali; Rauch, Carol A; Pantanowitz, Liron

2014-10-01

The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future. Copyright © 2014, American Society for Microbiology. All Rights Reserved.
Clinical Microbiology Informatics

PubMed Central

Sintchenko, Vitali; Rauch, Carol A.; Pantanowitz, Liron

2014-01-01

SUMMARY The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future. PMID:25278581
Global form and motion processing in healthy ageing.

PubMed

Agnew, Hannah C; Phillips, Louise H; Pilz, Karin S

2016-05-01

The ability to perceive biological motion has been shown to deteriorate with age, and it is assumed that older adults rely more on the global form than local motion information when processing point-light walkers. Further, it has been suggested that biological motion processing in ageing is related to a form-based global processing bias. Here, we investigated the relationship between older adults' preference for form information when processing point-light actions and an age-related form-based global processing bias. In a first task, we asked older (>60years) and younger adults (19-23years) to sequentially match three different point-light actions; normal actions that contained local motion and global form information, scrambled actions that contained primarily local motion information, and random-position actions that contained primarily global form information. Both age groups overall performed above chance in all three conditions, and were more accurate for actions that contained global form information. For random-position actions, older adults were less accurate than younger adults but there was no age-difference for normal or scrambled actions. These results indicate that both age groups rely more on global form than local motion to match point-light actions, but can use local motion on its own to match point-light actions. In a second task, we investigated form-based global processing biases using the Navon task. In general, participants were better at discriminating the local letters but faster at discriminating global letters. Correlations showed that there was no significant linear relationship between performance in the Navon task and biological motion processing, which suggests that processing biases in form- and motion-based tasks are unrelated. Copyright © 2016. Published by Elsevier B.V.
Thalamic Amnesia Mimicking Transient Global Amnesia.

PubMed

Giannantoni, Nadia M; Lacidogna, Giordano; Broccolini, Aldobrando; Pilato, Fabio; Profice, Paolo; Morosetti, Roberta; Caliandro, Pietro; Gambassi, Giovanni; Della Marca, Giacomo; Frisullo, Giovanni

2015-06-01

Transient global amnesia is a benign syndrome and one of the most frequent discharges from the emergency department that can hardly be distinguished from other mimicking diseases. No consensus in the evaluation of transient global amnesia has yet been found in the emergency setting. We describe a 69-year-old woman who presented to our emergency department with an abrupt onset of anterograde amnesia, preceded by a similar amnesic episode misinterpreted as transient global amnesia. Neuroradiologic, neuropsychological, and neurophysiological evaluations supported the diagnosis of vascular thalamic amnesia. We report a patient who clinically fulfilled transient global amnesia's criteria and in whom nevertheless was disclosed a thalamic ischemic lesion on neuroimaging.This case report highlights the importance of performing neuroradiologic screening in the emergency department even when clinical history and physical findings are highly suggestive for transient global amnesia.

Children inhibit global information when the forest is dense and local information when the forest is sparse.

PubMed

Krakowski, Claire-Sara; Borst, Grégoire; Vidal, Julie; Houdé, Olivier; Poirel, Nicolas

2018-09-01

Visual environments are composed of global shapes and local details that compete for attentional resources. In adults, the global level is processed more rapidly than the local level, and global information must be inhibited in order to process local information when the local information and global information are in conflict. Compared with adults, children present less of a bias toward global visual information and appear to be more sensitive to the density of local elements that constitute the global level. The current study aimed, for the first time, to investigate the key role of inhibition during global/local processing in children. By including two different conditions of global saliency during a negative priming procedure, the results showed that when the global level was salient (dense hierarchical figures), 7-year-old children and adults needed to inhibit the global level to process the local information. However, when the global level was less salient (sparse hierarchical figures), only children needed to inhibit the local level to process the global information. These results confirm a weaker global bias and the greater impact of saliency in children than in adults. Moreover, the results indicate that, regardless of age, inhibition of the most salient hierarchical level is systematically required to select the less salient but more relevant level. These findings have important implications for future research in this area. Copyright © 2018 Elsevier Inc. All rights reserved.
Seeing the Forest and the Trees: Default Local Processing in Individuals with High Autistic Traits Does Not Come at the Expense of Global Attention.

PubMed

Stevenson, Ryan A; Sun, Sol Z; Hazlett, Naomi; Cant, Jonathan S; Barense, Morgan D; Ferber, Susanne

2018-04-01

Atypical sensory perception is one of the most ubiquitous symptoms of autism, including a tendency towards a local-processing bias. We investigated whether local-processing biases were associated with global-processing impairments on a global/local attentional-scope paradigm in conjunction with a composite-face task. Behavioural results were related to individuals' levels of autistic traits, specifically the Attention to Detail subscale of the Autism Quotient, and the Sensory Profile Questionnaire. Individuals showing high rates of Attention to Detail were more susceptible to global attentional-scope manipulations, suggesting that local-processing biases associated with Attention to Detail do not come at the cost of a global-processing deficit, but reflect a difference in default global versus local bias. This relationship operated at the attentional/perceptual level, but not response criterion.
Collective network for computer structures

DOEpatents

Blumrich, Matthias A; Coteus, Paul W; Chen, Dong; Gara, Alan; Giampapa, Mark E; Heidelberger, Philip; Hoenicke, Dirk; Takken, Todd E; Steinmacher-Burow, Burkhard D; Vranas, Pavlos M

2014-01-07

A system and method for enabling high-speed, low-latency global collective communications among interconnected processing nodes. The global collective network optimally enables collective reduction operations to be performed during parallel algorithm operations executing in a computer structure having a plurality of the interconnected processing nodes. Router devices are included that interconnect the nodes of the network via links to facilitate performance of low-latency global processing operations at nodes of the virtual network. The global collective network may be configured to provide global barrier and interrupt functionality in asynchronous or synchronized manner. When implemented in a massively-parallel supercomputing structure, the global collective network is physically and logically partitionable according to the needs of a processing algorithm.
Collective network for computer structures

DOEpatents

Blumrich, Matthias A [Ridgefield, CT; Coteus, Paul W [Yorktown Heights, NY; Chen, Dong [Croton On Hudson, NY; Gara, Alan [Mount Kisco, NY; Giampapa, Mark E [Irvington, NY; Heidelberger, Philip [Cortlandt Manor, NY; Hoenicke, Dirk [Ossining, NY; Takken, Todd E [Brewster, NY; Steinmacher-Burow, Burkhard D [Wernau, DE; Vranas, Pavlos M [Bedford Hills, NY

2011-08-16

A system and method for enabling high-speed, low-latency global collective communications among interconnected processing nodes. The global collective network optimally enables collective reduction operations to be performed during parallel algorithm operations executing in a computer structure having a plurality of the interconnected processing nodes. Router devices ate included that interconnect the nodes of the network via links to facilitate performance of low-latency global processing operations at nodes of the virtual network and class structures. The global collective network may be configured to provide global barrier and interrupt functionality in asynchronous or synchronized manner. When implemented in a massively-parallel supercomputing structure, the global collective network is physically and logically partitionable according to needs of a processing algorithm.
The CARE guidelines: consensus-based clinical case report guideline development.

PubMed

Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2014-01-01

A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. Copyright © 2014 Reproduced with permission of Global Advances in Health and Medicine. Published by Elsevier Inc. All rights reserved.
[Modeling the academic performance of medical students in basic sciences and pre-clinical courses: a longitudinal study].

PubMed

Zúñiga, Denisse; Mena, Beltrán; Oliva, Rose; Pedrals, Nuria; Padilla, Oslando; Bitran, Marcela

2009-10-01

The study of predictors of academic performance is relevant for medical education. Most studies of academic performance use global ratings as outcome measure, and do not evaluate the influence of the assessment methods. To model by multivariate analysis, the academic performance of medical considering, besides academic and demographic variables, the methods used to assess students' learning and their preferred modes of information processing. Two hundred seventy two students admitted to the medical school of the Pontificia Universidad Católica de Chile from 2000 to 2003. Six groups of variables were studied to model the students' performance in five basic science courses (Anatomy, Biology, Calculus, Chemistry and Physics) and two pre-clinical courses (Integrated Medical Clinic I and IT). The assessment methods examined were multiple choice question tests, Objective Structured Clinical Examination and tutor appraisal. The results of the university admission tests (high school grades, mathematics and biology tests), the assessment methods used, the curricular year and previous application to medical school, were predictors of academic performance. The information processing modes influenced academic performance, but only in interaction with other variables. Perception (abstract or concrete) interacted with the assessment methods, and information use (active or reflexive), with sex. The correlation between the real and predicted grades was 0.7. In addition to the academic results obtained prior to university entrance, the methods of assessment used in the university and the information processing modes influence the academic performance of medical students in basic and preclinical courses.
Opisthorchiasis and viral hepatitis b: clinical cases.

PubMed

Kotelevska, Tetiana M; Pryimenko, Nataliia O; Dubynska, Galyna M; Iziumska, Olena M; Bodnar, Vadym A

2018-01-01

Introduction: Among the cases of biohelminthosis, which are registered in Ukraine, opisthorchiasis is the most common and constitutes the second largest centre in Europe. Due to the growth of migration processes and global tourism, opisthorchiasis is becoming increasingly relevant for the countries of the European Union and the United States. Under modern conditions, the clinical course of many infectious and parasitic diseases has changed. The aim: The present paper discusses and analyzes the cases of opisthorchiasis and hepatitis B virus which are challenging in terms of diagnostics and choice of treatment tactics. Conclusion: The course of acute infections, the formation of results and the effectiveness of treatment are influenced by a number of factors, among which mixed infections are of particular interest.
CURRENT PERSPECTIVES OF POTTER'S GLOBAL BIOETHICS AS A BRIDGE BETWEEN CLINICAL (PERSONALIZED) AND PUBLIC HEALTH ETHICS.

PubMed

Turina, Iva Sorta-Bilajac; Brkljacić, Morana; Grgas-Bile, Cecilija; Gajski, Domagoj; Racz, Aleksandar; Cengić, Tomislav

2015-12-01

In the context of modern scientific and technological developments in biomedicine and health care, and the potential consequences of their application on humans and the environment, Potter's global bioethics concept resurfaces. By actualizing Potter's original thoughts on individual bioethical issues, the universality of two of his books, which today represent the backbone of the world bioethical literature, "Bioethics--Bridge to the Future" and "Global Bioethics: Building on the Leopold Legacy", is emphasized. Potter's global bioethics today can legitimately be viewed as a bridge between clinical personalized ethics on the one hand and ethics of public health on the other.
Clinical and translational research in global health and emergency care: a research agenda.

PubMed

Runyon, Michael S; Sawe, Hendry R; Levine, Adam C; Pousson, Amelia; House, Darlene R; Agrawal, Pooja; Osei-Ampofo, Maxwell; Weiner, Scott G; Douglass, Katherine

2013-12-01

As policy-makers increasingly recognize emergency care to be a global health priority, the need for high-quality clinical and translational research in this area continues to grow. As part of the proceedings of the 2013 Academic Emergency Medicine consensus conference, this article discusses the importance of: 1) including clinical and translational research in the initial emergency care development plan, 2) defining the burden of acute disease and the barriers to conducting research in resource-limited settings, 3) assessing the appropriateness and effectiveness of local and global acute care guidelines within the local context, 4) studying the local research infrastructure needs to understand the best methods to build a sustainable research infrastructure, and 5) studying the long-term effects of clinical research programs on health care systems. © 2013 by the Society for Academic Emergency Medicine.
Improving quality for maternal care - a case study from Kerala, India

PubMed Central

Vlad, Ioana; Paily, VP; Sadanandan, Rajeev; Cluzeau, Françoise; Beena, M; Nair, Rajasekharan; Newbatt, Emma; Ghosh, Sujit; Sandeep, K; Chalkidou, Kalipso

2016-01-01

Background: The implementation of maternal health guidelines remains unsatisfactory, even for simple, well established interventions. In settings where most births occur in health facilities, as is the case in Kerala, India, preventing maternal mortality is linked to quality of care improvements. Context: Evidence-informed quality standards (QS), including quality statements and measurable structure and process indicators, are one innovative way of tackling the guideline implementation gap. Having adopted a zero tolerance policy to maternal deaths, the Government of Kerala worked in partnership with the Kerala Federation of Obstetricians & Gynaecologists (KFOG) and NICE International to select the clinical topic, develop and initiate implementation of the first clinical QS for reducing maternal mortality in the state. Description of practice: The NICE QS development framework was adapted to the Kerala context, with local ownership being a key principle. Locally generated evidence identified post-partum haemorrhage as the leading cause of maternal death, and as the key priority for the QS. A multidisciplinary group (including policy-makers, gynaecologists and obstetricians, nurses and administrators) was established. Multi-stakeholder workshops convened by the group ensured that the statements, derived from global and local guidelines, and their corresponding indicators were relevant and acceptable to clinicians and policy-makers in Kerala. Furthermore, it helped identify practical methods for implementing the standards and monitoring outcomes. Lessons learned: An independent evaluation of the project highlighted the equal importance of a strong evidence-base and an inclusive development process. There is no one-size-fits-all process for QS development; a principle-based approach might be a better guide for countries to adapt global evidence to their local context. PMID:27441084
Registration of PET and CT images based on multiresolution gradient of mutual information demons algorithm for positioning esophageal cancer patients.

PubMed

Jin, Shuo; Li, Dengwang; Wang, Hongjun; Yin, Yong

2013-01-07

Accurate registration of 18F-FDG PET (positron emission tomography) and CT (computed tomography) images has important clinical significance in radiation oncology. PET and CT images are acquired from (18)F-FDG PET/CT scanner, but the two acquisition processes are separate and take a long time. As a result, there are position errors in global and deformable errors in local caused by respiratory movement or organ peristalsis. The purpose of this work was to implement and validate a deformable CT to PET image registration method in esophageal cancer to eventually facilitate accurate positioning the tumor target on CT, and improve the accuracy of radiation therapy. Global registration was firstly utilized to preprocess position errors between PET and CT images, achieving the purpose of aligning these two images on the whole. Demons algorithm, based on optical flow field, has the features of fast process speed and high accuracy, and the gradient of mutual information-based demons (GMI demons) algorithm adds an additional external force based on the gradient of mutual information (GMI) between two images, which is suitable for multimodality images registration. In this paper, GMI demons algorithm was used to achieve local deformable registration of PET and CT images, which can effectively reduce errors between internal organs. In addition, to speed up the registration process, maintain its robustness, and avoid the local extremum, multiresolution image pyramid structure was used before deformable registration. By quantitatively and qualitatively analyzing cases with esophageal cancer, the registration scheme proposed in this paper can improve registration accuracy and speed, which is helpful for precisely positioning tumor target and developing the radiation treatment planning in clinical radiation therapy application.
Registration of PET and CT images based on multiresolution gradient of mutual information demons algorithm for positioning esophageal cancer patients

PubMed Central

Jin, Shuo; Li, Dengwang; Yin, Yong

2013-01-01

Accurate registration of 18F−FDG PET (positron emission tomography) and CT (computed tomography) images has important clinical significance in radiation oncology. PET and CT images are acquired from 18F−FDG PET/CT scanner, but the two acquisition processes are separate and take a long time. As a result, there are position errors in global and deformable errors in local caused by respiratory movement or organ peristalsis. The purpose of this work was to implement and validate a deformable CT to PET image registration method in esophageal cancer to eventually facilitate accurate positioning the tumor target on CT, and improve the accuracy of radiation therapy. Global registration was firstly utilized to preprocess position errors between PET and CT images, achieving the purpose of aligning these two images on the whole. Demons algorithm, based on optical flow field, has the features of fast process speed and high accuracy, and the gradient of mutual information‐based demons (GMI demons) algorithm adds an additional external force based on the gradient of mutual information (GMI) between two images, which is suitable for multimodality images registration. In this paper, GMI demons algorithm was used to achieve local deformable registration of PET and CT images, which can effectively reduce errors between internal organs. In addition, to speed up the registration process, maintain its robustness, and avoid the local extremum, multiresolution image pyramid structure was used before deformable registration. By quantitatively and qualitatively analyzing cases with esophageal cancer, the registration scheme proposed in this paper can improve registration accuracy and speed, which is helpful for precisely positioning tumor target and developing the radiation treatment planning in clinical radiation therapy application. PACS numbers: 87.57.nj, 87.57.Q‐, 87.57.uk PMID:23318381
Atypical Local Interference Affects Global Processing in Children with Neurofibromatosis Type 1.

PubMed

Payne, Jonathan M; Porter, Melanie A; Bzishvili, Samantha; North, Kathryn N

2017-05-01

To examine hierarchical visuospatial processing in children with neurofibromatosis type 1 (NF1), a single gene disorder associated with visuospatial impairments, attention deficits, and executive dysfunction. We used a modified Navon paradigm consisting of a large "global" shape composed of smaller "local" shapes that were either congruent (same) or incongruent (different) to the global shape. Participants were instructed to name either the global or local shape within a block. Reaction times, interference ratios, and error rates of children with NF1 (n=30) and typically developing controls (n=24) were compared. Typically developing participants demonstrated the expected global processing bias evidenced by a vulnerability to global interference when naming local stimuli without a cost of congruence when naming global stimuli. NF1 participants, however, experienced significant interference from the unattended level when naming both local and global levels of the stimuli. Findings suggest that children with NF1 do not demonstrate the typical human bias of processing visual information from a global perspective. (JINS, 2017, 23, 446-450).
Designing clinical trials to address the needs of childhood and adult asthma: the National Heart, Lung, and Blood Institute's AsthmaNet.

PubMed

Sutherland, E Rand; Busse, William W

2014-01-01

In 2008, the National Heart, Lung, and Blood Institute announced its intent to support a new asthma network known as AsthmaNet. This clinical trials consortium, now in its fifth year, has been charged with developing and executing clinical trials to address the most important asthma management questions and identify new treatment approaches in pediatric and adult patients. This review will discuss the organization of AsthmaNet and the scientific context in which the network was developed and began its work, report the results of an internal priority-setting exercise designed to guide the network's scientific strategy, and highlight the portfolio of clinical trials, proof-of-concept studies, and mechanistic studies planned for the 7-year period of the network to update the global asthma community regarding the progress and processes of the network. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
Collective intelligence for translational medicine: Crowdsourcing insights and innovation from an interdisciplinary biomedical research community.

PubMed

Budge, Eleanor Jane; Tsoti, Sandra Maria; Howgate, Daniel James; Sivakumar, Shivan; Jalali, Morteza

2015-01-01

Translational medicine bridges the gap between discoveries in biomedical science and their safe and effective clinical application. Despite the gross opportunity afforded by modern research for unparalleled advances in this field, the process of translation remains protracted. Efforts to expedite science translation have included the facilitation of interdisciplinary collaboration within both academic and clinical environments in order to generate integrated working platforms fuelling the sharing of knowledge, expertise, and tools to align biomedical research with clinical need. However, barriers to scientific translation remain, and further progress is urgently required. Collective intelligence and crowdsourcing applications offer the potential for global online networks, allowing connection and collaboration between a wide variety of fields. This would drive the alignment of biomedical science with biotechnology, clinical need, and patient experience, in order to deliver evidence-based innovation which can revolutionize medical care worldwide. Here we discuss the critical steps towards implementing collective intelligence in translational medicine using the experience of those in other fields of science and public health.
"Just-in-time" clinical information.

PubMed

Chueh, H; Barnett, G O

1997-06-01

The just-in-time (JIT) model originated in the manufacturing industry as a way to manage parts inventories process so that specific components could be made available at the appropriate times (that is, "just in time"). This JIT model can be applied to the management of clinical information inventories, so that clinicians can have more immediate access to the most current and relevant information at the time they most need it--when making clinical care decisions. The authors discuss traditional modes of managing clinical information, and then describe how a new, JIT model may be developed and implemented. They describe three modes of clinician-information interactions that a JIT model might employ, the scope of information that may be made available in a JIT model (global information or local, case-specific information), and the challenges posed by the implementation of such an information-access model. Finally, they discuss how JIT information access may change how physicians practice medicine, various ways JIT information may be delivered, and concerns about the trustworthiness of electronically published and accessed information resources.
Novel Phenotype Issues Raised in Cross-National Epidemiological Research on Drug Dependence

PubMed Central

Anthony, James C.

2010-01-01

Stage-transition models based on the American Diagnostic and Statistical Manual (DSM) generally are applied in epidemiology and genetics research on drug dependence syndromes associated with cannabis, cocaine, and other internationally regulated drugs (IRD). Difficulties with DSM stage-transition models have surfaced during cross-national research intended to provide a truly global perspective, such as the work of the World Mental Health Surveys (WMHS) Consortium. Alternative simpler dependence-related phenotypes are possible, including population-level count process models for steps early and before coalescence of clinical features into a coherent syndrome (e.g., zero-inflated Poisson regression). Selected findings are reviewed, based on ZIP modeling of alcohol, tobacco, and IRD count processes, with an illustration that may stimulate new research on genetic susceptibility traits. The annual National Surveys on Drug Use and Health can be readily modified for this purpose, along the lines of a truly anonymous research approach that can help make NSDUH-type cross-national epidemiological surveys more useful in the context of subsequent genome wide association (GWAS) research and post-GWAS investigations with a truly global health perspective. PMID:20201862
Quality Indicators for Global Benchmarking of Localized Prostate Cancer Management.

PubMed

Sampurno, Fanny; Zheng, Jia; Di Stefano, Lydia; Millar, Jeremy L; Foster, Claire; Fuedea, Ferran; Higano, Celestia; Hulan, Hartwig; Mark, Stephen; Moore, Caroline; Richardson, Alison; Sullivan, Frank; Wenger, Neil S; Wittmann, Daniela; Evans, Sue

2018-03-01

We sought to develop a core set of clinical indicators to enable international benchmarking of localized prostate cancer management using data available in the TrueNTH (True North) Global Registry. An international expert panel completed an online survey and participated in a face to face meeting. Participants included 3 urologists, 3 radiation oncologists, 2 psychologists, 1 medical oncologist, 1 nurse and 1 epidemiologist with prostate cancer expertise from a total of 7 countries. Current guidelines on prostate cancer treatment and potential quality indicators were identified from a literature review. These potential indicators were refined and developed through a modified Delphi process during which each panelist independently and repeatedly rated each indicator based on importance (satisfying the indicator demonstrated a provision of high quality care) and feasibility (the likelihood that data used to construct the indicator could be collected at a population level). The main outcome measure was items with panel agreement indicted by a disagreement index less 1, median importance 8.5 or greater and median feasibility 9 or greater. The expert panel endorsed 33 indicators. Seven of these 33 prostate cancer quality indicators assessed care relating to diagnosis, 7 assessed primary treatment, 1 assessed salvage treatment and 18 assessed health outcomes. We developed a set of quality indicators to measure prostate cancer care using numerous international evidence-based clinical guidelines. These indicators will be pilot tested in the TrueNTH Global Registry. Reports comparing indicator performance will subsequently be distributed to groups at participating sites with the purpose of improving the consistency and quality of prostate cancer management on a global basis. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
"Competing Conceptions of Globalization" Revisited: Relocating the Tension between World-Systems Analysis and Globalization Analysis

ERIC Educational Resources Information Center

Clayton, Thomas

2004-01-01

In recent years, many scholars have become fascinated by a contemporary, multidimensional process that has come to be known as "globalization." Globalization originally described economic developments at the world level. More specifically, scholars invoked the concept in reference to the process of global economic integration and the seemingly…
Health technopole: innovation applied to clinical engineering & health technology management education.

PubMed

Vilcahuaman, L; Rivas, R

2010-01-01

In the Peruvian Health System, Clinical Engineering does not exist as a topic of intervention. 59% of biomedical equipment is officially classified as operational, however next to apply the correct classification methodology and include security issues, only 10% of the equipment are suitable for use in patients. The serious consequences for patients, is opposite to the increased public investment in the health sector. Reversing this context leads to structural changes at all levels of the organization and they will be achievable only through an appropriate educational program. A strategy focused on joint of capacities called Health Technopole has managed to implement an innovative Model of Education in Healthcare Technology Management HTM and Clinical Engineering CE aimed at solving this problem. The proposal focused on strategies to strengthen the educational goals such as creating HTM & CE Units in hospitals, the implementation of the methodology: Problem Based Learning and Project Management in HTM & CE in classroom and on line courses. The process includes an effective interaction with global organizations through teleconferences, Internships, Workshops and Seminars. A key component was the sustained multidisciplinary approach. Health Technopole CENGETS is an expert adviser for the Ministry of Health and is called for trainings, design training programs for regional governments and also supports global organizations such as PAHO / WHO and ORAS / CONHU. The proposal of innovation applied to HTM & CE Education is effective and is a benchmark for similar countries.

Global/local processing of hierarchical visual stimuli in a conflict-choice task by capuchin monkeys (Sapajus spp.).

PubMed

Truppa, Valentina; Carducci, Paola; De Simone, Diego Antonio; Bisazza, Angelo; De Lillo, Carlo

2017-03-01

In the last two decades, comparative research has addressed the issue of how the global and local levels of structure of visual stimuli are processed by different species, using Navon-type hierarchical figures, i.e. smaller local elements that form larger global configurations. Determining whether or not the variety of procedures adopted to test different species with hierarchical figures are equivalent is of crucial importance to ensure comparability of results. Among non-human species, global/local processing has been extensively studied in tufted capuchin monkeys using matching-to-sample tasks with hierarchical patterns. Local dominance has emerged consistently in these New World primates. In the present study, we assessed capuchins' processing of hierarchical stimuli with a method frequently adopted in studies of global/local processing in non-primate species: the conflict-choice task. Different from the matching-to-sample procedure, this task involved processing local and global information retained in long-term memory. Capuchins were trained to discriminate between consistent hierarchical stimuli (similar global and local shape) and then tested with inconsistent hierarchical stimuli (different global and local shapes). We found that capuchins preferred the hierarchical stimuli featuring the correct local elements rather than those with the correct global configuration. This finding confirms that capuchins' local dominance, typically observed using matching-to-sample procedures, is also expressed as a local preference in the conflict-choice task. Our study adds to the growing body of comparative studies on visual grouping functions by demonstrating that the methods most frequently used in the literature on global/local processing produce analogous results irrespective of extent of the involvement of memory processes.
Clinical and pathological implications of miRNA in bladder cancer.

PubMed

Braicu, Cornelia; Cojocneanu-Petric, Roxana; Chira, Sergiu; Truta, Anamaria; Floares, Alexandru; Petrut, Bogdan; Achimas-Cadariu, Patriciu; Berindan-Neagoe, Ioana

2015-01-01

MicroRNAs (miRNAs) are small, noncoding RNA species with a length of 20-22 nucleotides that are recognized as essential regulators of relevant molecular mechanisms, including carcinogenesis. Current investigations show that miRNAs are detectable not only in different tissue types but also in a wide range of biological fluids, either free or trapped in circulating microvesicles. miRNAs were proven to be involved in cell communication, both in pathological and physiological processes. Evaluation of the global expression patterns of miRNAs provides key opportunities with important practical applications, taking into account that they modulate essential biological processes such as epithelial to mesenchymal transition, which is a mechanism relevant in bladder cancer. miRNAs collected from biological specimens can furnish valuable evidence with regard to bladder cancer oncogenesis, as they also have been linked to clinical outcomes in urothelial carcinoma. Therefore, a single miRNA or a signature of multiple miRNAs may improve risk stratification of patients and may supplement the histological diagnosis of urological tumors, particularly for bladder cancer.
Attentional selection of relative SF mediates global versus local processing: evidence from EEG.

PubMed

Flevaris, Anastasia V; Bentin, Shlomo; Robertson, Lynn C

2011-06-13

Previous research on functional hemispheric differences in visual processing has associated global perception with low spatial frequency (LSF) processing biases of the right hemisphere (RH) and local perception with high spatial frequency (HSF) processing biases of the left hemisphere (LH). The Double Filtering by Frequency (DFF) theory expanded this hypothesis by proposing that visual attention selects and is directed to relatively LSFs by the RH and relatively HSFs by the LH, suggesting a direct causal relationship between SF selection and global versus local perception. We tested this idea in the current experiment by comparing activity in the EEG recorded at posterior right and posterior left hemisphere sites while participants' attention was directed to global or local levels of processing after selection of relatively LSFs versus HSFs in a previous stimulus. Hemispheric asymmetry in the alpha band (8-12 Hz) during preparation for global versus local processing was modulated by the selected SF. In contrast, preparatory activity associated with selection of SF was not modulated by the previously attended level (global/local). These results support the DFF theory that top-down attentional selection of SF mediates global and local processing.
Clinical Holistic Medicine: A Pilot Study on HIV and Quality of Life and a Suggested Cure for HIV and AIDS

PubMed Central

Ventegodt, Søren; Flensborg-Madsen, Trine; Andersen, Niels Jørgen; Morad, Mohammed; Merrick, Joav

2004-01-01

This study was undertaken to examine the association between the immunological impact of HIV (measured by CD4 count) and global self-assessed quality of life (QOL) (measured with QOL1) for people suffering from HIV, to see if the connection was large and statistically strong enough to support our hypothesis of a strong QOL-immunological connection through the nonspecific, nonreceptor-mediated immune system, and thus to give a rationale for a holistic cure for HIV. This cross-sectional population study in Uganda included 20 HIV infected persons with no symptoms of AIDS and a CD4 count above 200 mill./liter. The main outcome measures were CD4 count, global QOL measured with the validated questionnaire QOL1, translated to Luganda and translated back to English. We found a large, clinically significant correlation between the number of T-helper cells (CD4) and global self-assessed quality of life (QOL1) (r = 0.57, p = 0.021), when controlled for age, gender, and years of infection. Together with other studies and holistic medicine theory, the results have given rationale for a holistic cure for HIV. We suggest, based on our findings and theoretical considerations, that HIV patients who improve their global QOL, also will improve their CD4 counts. Using the technique of holistic medicine based on the life mission theory and the holistic process theory of healing, we hypothesize that the improvement of QOL can have sufficient biological effect on the CD4, which could avoid or postpone the development of AIDS. A holistic HIV/AIDS cure improving the QOL draws on hidden resources in the person and is thus affordable for everybody. Improving global QOL also means a higher consciousness and a more ethical attitude, making it more difficult for the HIV-infected person to pass on the infection. PMID:15167940
A Comparison of Change in the 0–10 Numeric Rating Scale to a Pain Relief Scale and Global Medication Performance Scale in a Short-term Clinical Trial of Breakthrough Pain Intensity

PubMed Central

Farrar, John T.; Polomano, Rosemary C.; Berlin, Jesse A.; Strom, Brian L.

2010-01-01

Background Pain intensity is commonly reported using a 0–10 numeric rating scale in breakthrough pain clinical trials. Analysis of the change on the Pain Intensity Numerical Rating Scale as a proportion as most consistently correlated with clinically important differences reported on the Patient Global Impression of Change. The analysis of data using a different global outcome measures and the pain relief scale will extend our understanding of these measures. Use of the pain relief scale is also explored in this study Methods Data came from the open titration phase of a multiple crossover, randomized, double-blind clinical trial comparing oral transmucosal fentanyl citrate to immediate-release oral morphine sulfate for treatment of cancer-related breakthrough pain. Raw and percent changes in the pain intensity scores on 1,307 from 134 oral transmucosal fentanyl citrate-naive patients were compared to the clinically relevant secondary outcomes of the pain relief verbal response scale and the global medication performance. The changes in raw and percent change were assessed over time and compared to the ordinal pain relief verbal response scale and global medication performance scales. Results The p-value of the interaction between the raw pain intensity difference was significant but not for the percent pain intensity difference score over 4 15 minute time periods (p = 0.034 and p = 0.26 respectively), in comparison with the ordinal pain relief verbal response scale (p = 0.0048 and p = 0.36 respectively), and global medication performance categories (p = 0.048 and p = 0.45 respectively). Conclusion The change in pain intensity in breakthrough pain was more consistent over time and when compared to both the pain relief verbal response scale and global medication performance scale when the percent change is used rather than raw pain intensity difference. PMID:20463579
A comparison of change in the 0-10 numeric rating scale to a pain relief scale and global medication performance scale in a short-term clinical trial of breakthrough pain intensity.

PubMed

Farrar, John T; Polomano, Rosemary C; Berlin, Jesse A; Strom, Brian L

2010-06-01

Pain intensity is commonly reported using a 0-10 Numeric Rating Scale in pain clinical trials. Analysis of the change on the Pain Intensity Numerical Rating Scale as a proportion has most consistently correlated with clinically important differences reported on the patient's global impression of change. The correlation of data from patients with breakthrough pain with a Pain Relief Scale and a different global outcome measures will extend our understanding of these measures. Data were obtained from the open titration phase of a multiple crossover, randomized, double-blind clinical trial comparing oral transmucosal fentanyl citrate with immediate-release oral morphine sulfate for the treatment of cancer-related breakthrough pain. Raw and percentage changes in the pain intensity scores from 1,307 episodes of pain in 134 oral transmucosal fentanyl citrate-naïve patients were correlated with the clinically relevant secondary outcomes of Pain Relief Verbal Response Scale and the global medication performance scale. The changes in raw and percentage change were assessed over time and compared with the ordinal Pain Relief Verbal Response Scale and Global Medication Performance Scale. The P value of the interaction between the raw pain intensity difference was significant (P = 0.034) for four 15-min time periods but not for the percentage pain intensity difference score (P = 0.26). We found similar results in comparison with the ordinal Pain Relief Verbal Response Scale (P = 0.0048 and P = 0.36 respectively) and global medication performance categories (P = 0.048 and P = 0.45, respectively). The change in pain intensity in breakthrough pain was more consistent over time and when compared with both the Pain Relief Verbal Response Scale and the Global Medication Performance Scale when the percentage change is used rather than raw pain intensity difference.
Fatigue as a Driver of Overall Quality of Life in Cancer Patients.

PubMed

McCabe, Ryan M; Grutsch, James F; Braun, Donald P; Nutakki, Swetha B

2015-01-01

This manuscript describes an approach for analyzing large amounts of disparate clinical data to elucidate the most impactful factor(s) that relate to a meaningful clinical outcome, in this case, the quality of life of cancer patients. The relationships between clinical and quality of life variables were evaluated using the EORTC QLQ-C30 global health domain--a validated surrogate variable for overall cancer patient well-being. A cross-sectional study design was used to evaluate the determinants of global health in cancer patients who initiated treatment at two regional medical centers between January 2001 and December 2009. Variables analyzed included 15 EORTC QLQ-C30 scales, age at diagnosis, gender, newly diagnosed/ recurrent disease status, and stage. The decision tree algorithm, perhaps unfamiliar to practicing clinicians, evaluates the relative contribution of individual parameters in classifying a clinically meaningful functional endpoint, such as the global health of a patient. Multiple patient characteristics were identified as important contributors. Fatigue, in particular, emerged as the most prevalent indicator of cancer patients' quality of life in 16/23 clinically relevant subsets. This analysis allowed results to be stated in a clinically-intuitive, rule set format using the language and quantities of the Quality of Life (QoL) tool itself. By applying the classification algorithms to a large data set, identification of fatigue as a root factor in driving global health and overall QoL was revealed. The ability to practice mining of clinical data sets to uncover critical clinical insights that are immediately applicable to patient care practices is illustrated.
Fatigue as a Driver of Overall Quality of Life in Cancer Patients

PubMed Central

McCabe, Ryan M.; Grutsch, James F.; Braun, Donald P.; Nutakki, Swetha B.

2015-01-01

Background This manuscript describes an approach for analyzing large amounts of disparate clinical data to elucidate the most impactful factor(s) that relate to a meaningful clinical outcome, in this case, the quality of life of cancer patients. The relationships between clinical and quality of life variables were evaluated using the EORTC QLQ-C30 global health domain—a validated surrogate variable for overall cancer patient well-being. Methods A cross-sectional study design was used to evaluate the determinants of global health in cancer patients who initiated treatment at two regional medical centers between January 2001 and December 2009. Variables analyzed included 15 EORTC QLQ-C30 scales, age at diagnosis, gender, newly diagnosed/ recurrent disease status, and stage. The decision tree algorithm, perhaps unfamiliar to practicing clinicians, evaluates the relative contribution of individual parameters in classifying a clinically meaningful functional endpoint, such as the global health of a patient. Findings Multiple patient characteristics were identified as important contributors. Fatigue, in particular, emerged as the most prevalent indicator of cancer patients’ quality of life in 16/23 clinically relevant subsets. This analysis allowed results to be stated in a clinically-intuitive, rule set format using the language and quantities of the Quality of Life (QoL) tool itself. Interpretation By applying the classification algorithms to a large data set, identification of fatigue as a root factor in driving global health and overall QoL was revealed. The ability to practice mining of clinical data sets to uncover critical clinical insights that are immediately applicable to patient care practices is illustrated. PMID:26070133
The Importance of Global Health Experiences in the Development of New Cardiologists

PubMed Central

Abdalla, Marwah; Kovach, Neal; Liu, Connie; Damp, Julie B.; Jahangir, Eiman; Hilliard, Anthony; Gopinathannair, Rakesh; Abu-Fadel, Mazen S.; El Chami, Mikhael F.; Gafoor, Sameer; Vedanthan, Rajesh; Sanchez-Shields, Monica; George, Jon C.; Priester, Tiffany; Alasnag, Mirvat; Barker, Colin; Freeman, Andrew M.

2016-01-01

As the global burden of cardiovascular disease continues to increase worldwide, nurturing the development of early-career cardiologists interested in global health is essential in order to create a cadre of providers with the skill set to prevent and treat cardiovascular diseases in international settings. As such, interest in global health has increased among cardiology trainees and early-career cardiologists over the past decade. International clinical and research experiences abroad present an additional opportunity for growth and development beyond traditional cardiovascular training. We describe the American College of Cardiology International Cardiovascular Exchange Database, a new resource for cardiologists interested in pursuing short-term clinical exchange opportunities abroad, and report some of the benefits and challenges of global health cardiovascular training in both resource-limited and resource-abundant settings. PMID:26763797
A new model for graduate education and innovation in medical technology.

PubMed

Yazdi, Youseph; Acharya, Soumyadipta

2013-09-01

We describe a new model of graduate education in bioengineering innovation and design- a year long Master's degree program that educates engineers in the process of healthcare technology innovation for both advanced and low-resource global markets. Students are trained in an iterative "Spiral Innovation" approach that ensures early, staged, and repeated examination of all key elements of a successful medical device. This includes clinical immersion based problem identification and assessment (at Johns Hopkins Medicine and abroad), team based concept and business model development, and project planning based on iterative technical and business plan de-risking. The experiential, project based learning process is closely supported by several core courses in business, design, and engineering. Students in the program work on two team based projects, one focused on addressing healthcare needs in advanced markets and a second focused on low-resource settings. The program recently completed its fourth year of existence, and has graduated 61 students, who have continued on to industry or startups (one half), additional graduate education, or medical school (one third), or our own Global Health Innovation Fellowships. Over the 4 years, the program has sponsored 10 global health teams and 14 domestic/advanced market medtech teams, and launched 5 startups, of which 4 are still active. Projects have attracted over US$2.5M in follow-on awards and grants, that are supporting the continued development of over a dozen projects.
Vascular disease and risk factors are associated with cognitive decline in the alzheimer disease spectrum.

PubMed

Lorius, Natacha; Locascio, Joseph J; Rentz, Dorene M; Johnson, Keith A; Sperling, Reisa A; Viswanathan, Anand; Marshall, Gad A

2015-01-01

We investigated the relationship between vascular disease and risk factors versus cognitive decline cross-sectionally and longitudinally in normal older control, mild cognitive impairment, and mild Alzheimer disease (AD) dementia subjects. A total of 812 participants (229 normal older control, 395 mild cognitive impairment, 188 AD) underwent cognitive testing, brain magnetic resonance imaging, and clinical evaluations at baseline and over a period of 3 years. General linear, longitudinal mixed-effects, and Cox proportional hazards models were used. Greater homocysteine level and white matter hyperintensity volume were associated with processing speed impairment (homocysteine: P=0.02; white matter hyperintensity: P<0.0001); greater Vascular Index score was associated with memory impairment (P=0.007); and greater number of apolipoprotein E ε4 (APOE4) alleles was associated with global cognitive impairment (P=0.007) at baseline. Apolipoprotein E ε4 was associated with greater rate of increase in global cognitive impairment (P=0.002) and processing speed impairment (P=0.001) over time, whereas higher total cholesterol was associated with greater rate of increase in global cognitive impairment (P=0.02) and memory impairment (P=0.06) over time. These results suggest a significant association of increased vascular disease and risk factors with cognitive impairment at baseline and over time in the AD spectrum in a sample that was selected to have low vascular burden at baseline.
Defining a Leader Role curriculum for radiation oncology: A global Delphi consensus study.

PubMed

Turner, Sandra; Seel, Matthew; Trotter, Theresa; Giuliani, Meredith; Benstead, Kim; Eriksen, Jesper G; Poortmans, Philip; Verfaillie, Christine; Westerveld, Henrike; Cross, Shamira; Chan, Ming-Ka; Shaw, Timothy

2017-05-01

The need for radiation oncologists and other radiation oncology (RO) professionals to lead quality improvement activities and contribute to shaping the future of our specialty is self-evident. Leadership knowledge, skills and behaviours, like other competencies, can be learned (Blumenthal et al., 2012). The objective of this study was to define a globally applicable competency set specific to radiation oncology for the CanMEDS Leader Role (Frank et al., 2015). A modified Delphi consensus process delivering two rounds of on-line surveys was used. Participants included trainees, radiation/clinical oncologists and other RO team members (radiation therapists, physicists, and nurses), professional educators and patients. 72 of 95 (76%) invitees from nine countries completed the Round 1 (R1) survey. Of the 72 respondents to RI, 70 completed Round 2 (R2) (97%). In R1, 35 items were deemed for 'inclusion' and 21 for 'exclusion', leaving 41 'undetermined'. After review of items, informed by participant comments, 14 competencies from the 'inclusion' group went into the final curriculum; 12 from the 'undetermined' group went to R2. In R2, 6 items reached consensus for inclusion. This process resulted in 20 RO Leader Role competencies with apparent global applicability. This is the first step towards developing learning, teaching and assessment tools for this important area of training. Copyright © 2017 Elsevier B.V. All rights reserved.
The influence of visual and phonological features on the hemispheric processing of hierarchical Navon letters.

PubMed

Aiello, Marilena; Merola, Sheila; Lasaponara, Stefano; Pinto, Mario; Tomaiuolo, Francesco; Doricchi, Fabrizio

2018-01-31

The possibility of allocating attentional resources to the "global" shape or to the "local" details of pictorial stimuli helps visual processing. Investigations with hierarchical Navon letters, that are large "global" letters made up of small "local" ones, consistently demonstrate a right hemisphere advantage for global processing and a left hemisphere advantage for local processing. Here we investigated how the visual and phonological features of the global and local components of Navon letters influence these hemispheric advantages. In a first study in healthy participants, we contrasted the hemispheric processing of hierarchical letters with global and local items competing for response selection, to the processing of hierarchical letters in which a letter, a false-letter conveying no phonological information or a geometrical shape presented at the unattended level did not compete for response selection. In a second study, we investigated the hemispheric processing of hierarchical stimuli in which global and local letters were both visually and phonologically congruent (e.g. large uppercase G made of smaller uppercase G), visually incongruent and phonologically congruent (e.g. large uppercase G made of small lowercase g) or visually incongruent and phonologically incongruent (e.g. large uppercase G made of small lowercase or uppercase M). In a third study, we administered the same tasks to a right brain damaged patient with a lesion involving pre-striate areas engaged by global processing. The results of the first two experiments showed that the global abilities of the left hemisphere are limited because of its strong susceptibility to interference from local letters even when these are irrelevant to the task. Phonological features played a crucial role in this interference because the interference was entirely maintained also when letters at the global and local level were presented in different uppercase vs. lowercase formats. In contrast, when local features conveyed no phonological information, the left hemisphere showed preserved global processing abilities. These findings were supported by the study of the right brain damaged patient. These results offer a new look at the hemispheric dominance in the attentional processing of the global and local levels of hierarchical stimuli. Copyright © 2017 Elsevier Ltd. All rights reserved.
Health professionals' decision-making in wound management: a grounded theory.

PubMed

Gillespie, Brigid M; Chaboyer, Wendy; St John, Winsome; Morley, Nicola; Nieuwenhoven, Paul

2015-06-01

To develop a conceptual understanding of the decision-making processes used by healthcare professionals in wound care practice. With the global move towards using an evidence-base in standardizing wound care practices and the need to reduce hospital wound care costs, it is important to understand health professionals' decision-making in this important yet under-researched area. A grounded theory approach was used to explore clinical decision-making of healthcare professionals in wound care practice. Interviews were conducted with 20 multi-disciplinary participants from nursing, surgery, infection control and wound care who worked at a metropolitan hospital in Australia. Data were collected during 2012-2013. Constant comparative analysis underpinned by Strauss and Corbin's framework was used to identify clinical decision-making processes. The core category was 'balancing practice-based knowledge with evidence-based knowledge'. Participants' clinical practice and actions embedded the following processes: 'utilizing the best available information', 'using a consistent approach in wound assessment' and 'using a multidisciplinary approach'. The substantive theory explains how practice and evidence knowledge was balanced and the variation in use of intuitive practice-based knowledge versus evidence-based knowledge. Participants considered patients' needs and preferences, costs, outcomes, technologies, others' expertise and established practices. Participants' decision-making tended to be more heavily weighted towards intuitive practice-based processes. These findings offer a better understanding of the processes used by health professionals' in their decision-making in wound care. Such an understanding may inform the development of evidence-based interventions that lead to better patient outcomes. © 2014 John Wiley & Sons Ltd.
Local and Global Cross-Modal Influences between Vision and Hearing, Tasting, Smelling, or Touching

ERIC Educational Resources Information Center

Forster, Jens

2011-01-01

It is suggested that the distinction between global versus local processing styles exists across sensory modalities. Activation of one-way of processing in one modality should affect processing styles in a different modality. In 12 studies, auditory, haptic, gustatory or olfactory global versus local processing was induced, and participants were…
Global Biology Research Program: Biogeochemical Processes in Wetlands

NASA Technical Reports Server (NTRS)

Bartlett, D. S. (Editor)

1984-01-01

The results of a workshop examining potential NASA contributions to research on wetland processes as they relate to global biogeochemical cycles are summarized. A wetlands data base utilizing remotely sensed inventories, studies of wetland/atmosphere exchange processes, and the extrapolation of local measurements to global biogeochemical cycling processes were identified as possible areas for NASA support.
Metabolite profiling of a NIST Standard Reference Material for human plasma (SRM 1950): GC-MS, LC-MS, NMR, and clinical laboratory analyses, libraries, and web-based resources.

PubMed

Simón-Manso, Yamil; Lowenthal, Mark S; Kilpatrick, Lisa E; Sampson, Maureen L; Telu, Kelly H; Rudnick, Paul A; Mallard, W Gary; Bearden, Daniel W; Schock, Tracey B; Tchekhovskoi, Dmitrii V; Blonder, Niksa; Yan, Xinjian; Liang, Yuxue; Zheng, Yufang; Wallace, William E; Neta, Pedatsur; Phinney, Karen W; Remaley, Alan T; Stein, Stephen E

2013-12-17

Recent progress in metabolomics and the development of increasingly sensitive analytical techniques have renewed interest in global profiling, i.e., semiquantitative monitoring of all chemical constituents of biological fluids. In this work, we have performed global profiling of NIST SRM 1950, "Metabolites in Human Plasma", using GC-MS, LC-MS, and NMR. Metabolome coverage, difficulties, and reproducibility of the experiments on each platform are discussed. A total of 353 metabolites have been identified in this material. GC-MS provides 65 unique identifications, and most of the identifications from NMR overlap with the LC-MS identifications, except for some small sugars that are not directly found by LC-MS. Also, repeatability and intermediate precision analyses show that the SRM 1950 profiling is reproducible enough to consider this material as a good choice to distinguish between analytical and biological variability. Clinical laboratory data shows that most results are within the reference ranges for each assay. In-house computational tools have been developed or modified for MS data processing and interactive web display. All data and programs are freely available online at http://peptide.nist.gov/ and http://srmd.nist.gov/ .
Global Access Programs: A Collaborative Approach for Effective Implementation and Management.

PubMed

Ainge, Debra; Aitken, Suzanne; Corbett, Mark; De-Keyzer, David

Global access programs (GAPs) provide access to medicinal products for patients with serious medical conditions and no commercially available treatment options. Providing early access to medicines can be challenging for a pharmaceutical company. The demand for a GAP often occurs at a time when other activities are the prime focus, such as delivery of pivotal clinical trials or gaining of marketing authorization. Furthermore, the skills, experience, and infrastructure necessary to implement and manage a successful GAP vary significantly from those required for regular clinical trial execution, and the regulatory environment presents its own challenges, with regulations often poorly defined and with considerable inter-country variation. This article considers the triggers for early access requests and examines the need for companies to develop a global strategy for GAPs in order to respond appropriately to requests for early access. It also provides a comprehensive overview of the processes for GAP set-up, implementation, management, and closure, along with the considerations affecting the type and scope of GAP, such as demand, regulatory feasibility, license status of the product, drug pricing structure, company strategy, costs, and product supply. Also discussed is the need for appropriate personnel to implement and manage the GAP, and when to consider collaboration with an external GAP provider. In summary, GAPs require careful and efficient planning and management, from set-up to closure. Well-run GAPs provide an ethical and regulatory-compliant pathway for access of new treatments to patients with serious conditions and an unmet medical need.
Coalition for Global Clinical Surgical Education: The Alliance for Global Clinical Training.

PubMed

Graf, Jahanara; Cook, Mackenzie; Schecter, Samuel; Deveney, Karen; Hofmann, Paul; Grey, Douglas; Akoko, Larry; Mwanga, Ali; Salum, Kitembo; Schecter, William

Assessment of the effect of the collaborative relationship between the high-income country (HIC) surgical educators of the Alliance for Global Clinical Training (Alliance) and the low-income country surgical educators at the Muhimbili University of Health and Allied Sciences/Muhimbili National Hospital (MUHAS/MNH), Dar Es Salaam, Tanzania, on the clinical global surgery training of the HIC surgical residents participating in the program. A retrospective qualitative analysis of Alliance volunteer HIC faculty and residents' reports, volunteer case lists and the reports of Alliance academic contributions to MUHAS/MNH from 2012 to 2017. In addition, a survey was circulated in late 2016 to all the residents who participated in the program since its inception. Twelve HIC surgical educators provided rotating 1-month teaching coverage at MUHAS/MNH between academic years 2012 and 2017 for a total of 21 months. During the same time period 11 HIC residents accompanied the HIC faculty for 1-month rotations. HIC surgery residents joined the MUHAS/MNH Department of Surgery, made significant teaching contributions, performed a wide spectrum of "open procedures" including hand-sewn intestinal anastomoses. Most had had either no or limited previous exposure to hand-sewn anastomoses. All of the residents commented that this was a maturing and challenging clinical rotation due to the complexity of the cases, the limited resources available and the ethical and emotional challenges of dealing with preventable complications and death in a resource constrained environment. The Alliance provides an effective clinical global surgery rotation at MUHAS/MNH for HIC Surgery Departments wishing to provide such an opportunity for their residents and faculty. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.
Enhancing Research Capacity for Global Health: Evaluation of a Distance-Based Program for International Study Coordinators

ERIC Educational Resources Information Center

Wilson, Lynda Law; Rice, Marti; Jones, Carolynn T.; Joiner, Cynthia; LaBorde, Jennifer; McCall, Kimberly; Jester, Penelope M.; Carter, Sheree C.; Boone, Chrissy; Onwuzuligbo, Uzoma; Koneru, Alaya

2013-01-01

Introduction: Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This article describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the…

Sarilumab for the treatment of rheumatoid arthritis.

PubMed

Cooper, Simon

2016-01-01

Simon Cooper has >18 years of global experience in the pharmaceutical industry. He joined Sanofi in July 2014 as the Vice President, Global Project Head. In his current position at Sanofi, Dr Cooper is responsible for the clinical development of sarilumab and the worldwide submission in rheumatoid arthritis. He joined Sanofi after serving as the Global Program Medical Director at Novartis since 2012. In this role, Dr Cooper acted as the clinical lead for secukinumab psoriasis submission. Prior to Novartis, Dr Cooper held various posts at Human Genome Sciences, USA, including Executive Director of Clinical Research, Senior Director of Clinical Research and Director of Clinical Research. During his tenure at Human Genome Sciences, USA, Dr Cooper was involved in the submission of belimumab leading to its approval for SLE, and was responsible for its subsequent clinical development program. Dr Cooper has also previously held positions at MedImmune Ltd, UK, Roche, Napp Pharmaceutical Research Ltd, Wyeth Research and Medeval Ltd. In these roles, his responsibilities ranged from medical oversight of clinical trials to medical support for commercial, medical affairs and business development. He received a Bachelor of Medicine and Bachelor of Surgery from University of Newcastle upon Tyne Medical School.
Developing Global Nurse Influencers.

PubMed

Spies, Lori A

2016-01-01

How can universities create engaged citizens and global leaders? Each year, a select group of advanced practice nursing students at Baylor University Louise Herrington School of Nursing travel to Africa for a month-long clinical mission experience. Students work alongside local and missionary healthcare providers in a comprehensive Christian outreach to the community at a high-volume clinic. Creating rich learning experiences in a global setting in significant and sustainable ways is difficult, but intentionally focusing on what we are called to do and who we serve provides ballast for faculty and students. The success of the trip in preparing students to be global influencers is evident by the work graduates elect to do around the world, following graduation.
Global tree network for computing structures enabling global processing operations

DOEpatents

Blumrich; Matthias A.; Chen, Dong; Coteus, Paul W.; Gara, Alan G.; Giampapa, Mark E.; Heidelberger, Philip; Hoenicke, Dirk; Steinmacher-Burow, Burkhard D.; Takken, Todd E.; Vranas, Pavlos M.

2010-01-19

A system and method for enabling high-speed, low-latency global tree network communications among processing nodes interconnected according to a tree network structure. The global tree network enables collective reduction operations to be performed during parallel algorithm operations executing in a computer structure having a plurality of the interconnected processing nodes. Router devices are included that interconnect the nodes of the tree via links to facilitate performance of low-latency global processing operations at nodes of the virtual tree and sub-tree structures. The global operations performed include one or more of: broadcast operations downstream from a root node to leaf nodes of a virtual tree, reduction operations upstream from leaf nodes to the root node in the virtual tree, and point-to-point message passing from any node to the root node. The global tree network is configurable to provide global barrier and interrupt functionality in asynchronous or synchronized manner, and, is physically and logically partitionable.
Global Consultation Processes: Lessons Learned from Refugee Teacher Consultation Research in Malaysia

ERIC Educational Resources Information Center

O'Neal, Colleen R.; Gosnell, Nicole M.; Ng, Wai Sheng; Clement, Jennifer; Ong, Edward

2018-01-01

The process of global consultation has received little attention despite its potential for promoting international mutual understanding with marginalized communities. This article details theory, entry, implementation, and evaluation processes for global consultation research, including lessons learned from our refugee teacher intervention. The…
Apathy, but not depression, is associated with executive dysfunction in cerebral small vessel disease

PubMed Central

Hollocks, Matthew J.; Morris, Robin G.; Markus, Hugh S.

2017-01-01

Objective To determine the prevalence of apathy and depression in cerebral small vessel disease (SVD), and the relationships between both apathy and depression with cognition. To examine whether apathy is specifically related to impairment in executive functioning and processing speed. Methods 196 patients with a clinical lacunar stroke and an anatomically corresponding lacunar infarct on MRI were compared to 300 stroke-free controls. Apathy and depression were measured using the Geriatric Depression Scale, and cognitive functioning was assessed using an SVD cognitive screening tool, the Brief Memory and Executive Test, which measures executive functioning/processing speed and memory/orientation. Path analysis and binary logistic regression were used to assess the relation between apathy, depression and cognitive impairment. Results 31 participants with SVD (15.8%) met criteria for apathy only, 23 (11.8%) for both apathy and depression, and 2 (1.0%) for depression only. In the SVD group the presence of apathy was related to global cognition, and specifically to impaired executive functioning/processing speed, but not memory/orientation. The presence of depression was not related to global cognition, impaired executive functioning/processing speed or memory/orientation. Conclusions Apathy is a common feature of SVD and is associated with impaired executive functioning/processing speed suggesting the two may share biological mechanisms. Screening for apathy should be considered in SVD, and further work is required to develop and evaluate effective apathy treatment or management in SVD. PMID:28493898
TRANSCULTURALIZATION RECOMMENDATIONS FOR DEVELOPING LATIN AMERICAN CLINICAL PRACTICE ALGORITHMS IN ENDOCRINOLOGY--PROCEEDINGS OF THE 2015 PAN-AMERICAN WORKSHOP BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY.

PubMed

Mechanick, Jeffrey I; Harrell, R Mack; Allende-Vigo, Myriam Z; Alvayero, Carlos; Arita-Melzer, Onix; Aschner, Pablo; Camacho, Pauline M; Castillo, Rogelio Zacarias; Cerdas, Sonia; Coutinho, Walmir F; Davidson, Jaime A; Garber, Jeffrey R; Garvey, W Timothy; González, Fernando Javier Lavalle; Granados, Denis O; Hamdy, Osama; Handelsman, Yehuda; Jiménez-Navarrete, Manuel Francisco; Lupo, Mark A; Mendoza, Enrique J; Jiménez-Montero, José G; Zangeneh, Farhad

2016-04-01

The American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) convened their first Workshop for recommendations to optimize Clinical Practice Algorithm (CPA) development for Latin America (LA) in diabetes (focusing on glycemic control), obesity (focusing on weight loss), thyroid (focusing on thyroid nodule diagnostics), and bone (focusing on postmenopausal osteoporosis) on February 28, 2015, in San Jose, Costa Rica. A standardized methodology is presented incorporating various transculturalization factors: resource availability (including imaging equipment and approved pharmaceuticals), health care professional and patient preferences, lifestyle variables, socio-economic parameters, web-based global accessibility, electronic implementation, and need for validation protocols. A standardized CPA template with node-specific recommendations to assist the local transculturalization process is provided. Participants unanimously agreed on the following five overarching principles for LA: (1) there is only one level of optimal endocrine care, (2) hemoglobin A1C should be utilized at every level of diabetes care, (3) nutrition education and increased pharmaceutical options are necessary to optimize the obesity care model, (4) quality neck ultrasound must be part of an optimal thyroid nodule care model, and (5) more scientific evidence is needed on osteoporosis prevalence and cost to justify intervention by governmental health care authorities. This 2015 AACE/ACE Workshop marks the beginning of a structured activity that assists local experts in creating culturally sensitive, evidence-based, and easy-to-implement tools for optimizing endocrine care on a global scale.
Current issues and actions in radiation protection of patients.

PubMed

Holmberg, Ola; Malone, Jim; Rehani, Madan; McLean, Donald; Czarwinski, Renate

2010-10-01

Medical application of ionizing radiation is a massive and increasing activity globally. While the use of ionizing radiation in medicine brings tremendous benefits to the global population, the associated risks due to stochastic and deterministic effects make it necessary to protect patients from potential harm. Current issues in radiation protection of patients include not only the rapidly increasing collective dose to the global population from medical exposure, but also that a substantial percentage of diagnostic imaging examinations are unnecessary, and the cumulative dose to individuals from medical exposure is growing. In addition to this, continued reports on deterministic injuries from safety related events in the medical use of ionizing radiation are raising awareness on the necessity for accident prevention measures. The International Atomic Energy Agency is engaged in several activities to reverse the negative trends of these current issues, including improvement of the justification process, the tracking of radiation history of individual patients, shared learning of safety significant events, and the use of comprehensive quality audits in the clinical environment. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
The diffusion of medical technology, local conditions, and technology re-invention: a comparative case study on coronary stenting.

PubMed

Hashimoto, Hideki; Noguchi, Haruko; Heidenreich, Paul; Saynina, Olga; Moreland, Abigail; Miyazaki, Shunichi; Ikeda, Shunya; Kaneko, Yoshihiro; Ikegami, Naoki

2006-12-01

Innovation of medical technology is a major driving force behind the increase in medical expenditures in developed countries. Previous studies identified that the diffusion of medical technology varied across countries according to the characteristics of regulatory policy and payment systems. Based on Roger's diffusion of innovation theory, this study purported to see how local practice norms, the evolving nature of diffusing technology, and local clinical needs in addition to differences in politico-economic systems would affect the process of innovation diffusion. Taking a case of coronary stenting, an innovative therapeutic technology in early 1990s, we provided a case study of hospital-based data between two teaching high-tech hospitals in Japan and the US for discussion. Stenting began to be widely used in both countries when complementary new technology modified its clinical efficacy, but the diffusion process still differed between the two hospitals due to (1) distinctive payment systems for hospitals and physicians, (2) practice norms in favor of percutaneous intervention rather than bypass surgery that was shaped by payment incentives and cultural attitudes, and (3) local patient's clinical characteristics that the technology had to be tailored for. The case study described the diffusion of stent technology as a dynamic process between patients, physicians, hospitals, health care systems, and technology under global and local conditions.
The Global in Global Health is Not a Given.

PubMed

Mason, Paul H; Kerridge, Ian; Lipworth, Wendy

2017-04-01

AbstractThe process of globalization is commonly espoused as a means for promoting global health. Efforts to "go global" can, however, easily go awry as a result of lack of attention to local social, economic, and political contexts and/or as a result of commercial and political imperatives that allow local populations to be exploited. Critical analysis of the processes of globalization is necessary to better understand the local particularities of global projects and confront challenges more transparently. We illustrate the potential adverse impacts of globalization in the global health setting, through examination of international tuberculosis control, global mental health, and the establishment of transnational biobank networks.
[Changes by Balint group education: experience with residents in family medicine].

PubMed

Laperrière, S; Turgeon, J

1993-09-01

The article is about the change observed in participants in a training course by the Balint groups. The authors' experiment is aimed at residents in family medicine. It involves both the psychiatrist and physician, leader and participant. Psychic functioning as a process is applied to presentation, discussions and leadership. The optimum clinical understanding of this training strives for development within the group itself. The authors consider two factors that come into play: symbolization and awareness. These concepts are developed to support the notion of a global approach.
The continuum of personalized cardiovascular medicine: a position paper of the European Society of Cardiology.

PubMed

Kirchhof, Paulus; Sipido, Karin R; Cowie, Martin R; Eschenhagen, Thomas; Fox, Keith A A; Katus, Hugo; Schroeder, Stefan; Schunkert, Heribert; Priori, Silvia

2014-12-07

There is strong need to develop the current stratified practice of CVD management into a better personalized cardiovascular medicine, within a broad framework of global patient care. Clinical information obtained from history and physical examination, functional and imaging studies, biochemical biomarkers, genetic/epigenetic data, and pathophysiological insights into disease-driving processes need to be integrated into a new taxonomy of CVDs to allow personalized disease management. This has the potential for major health benefits for the population suffering from cardiovascular diseases.
The Role of Musical Experience in Hemispheric Lateralization of Global and Local Auditory Processing.

PubMed

Black, Emily; Stevenson, Jennifer L; Bish, Joel P

2017-08-01

The global precedence effect is a phenomenon in which global aspects of visual and auditory stimuli are processed before local aspects. Individuals with musical experience perform better on all aspects of auditory tasks compared with individuals with less musical experience. The hemispheric lateralization of this auditory processing is less well-defined. The present study aimed to replicate the global precedence effect with auditory stimuli and to explore the lateralization of global and local auditory processing in individuals with differing levels of musical experience. A total of 38 college students completed an auditory-directed attention task while electroencephalography was recorded. Individuals with low musical experience responded significantly faster and more accurately in global trials than in local trials regardless of condition, and significantly faster and more accurately when pitches traveled in the same direction (compatible condition) than when pitches traveled in two different directions (incompatible condition) consistent with a global precedence effect. In contrast, individuals with high musical experience showed less of a global precedence effect with regards to accuracy, but not in terms of reaction time, suggesting an increased ability to overcome global bias. Further, a difference in P300 latency between hemispheres was observed. These findings provide a preliminary neurological framework for auditory processing of individuals with differing degrees of musical experience.
Implementing the dynamic appraisal of situational aggression in mental health units.

PubMed

Lantta, Tella; Daffern, Michael; Kontio, Raija; Välimäki, Maritta

2015-01-01

The aims of this study are to explain the intervention of implementing a structured violence risk assessment procedure in mental health inpatient units using the Ottawa Model of Research Use (OMRU) as a guiding framework and to consider nurses' perspectives of its clinical utility and implementation process. Patient aggression toward staff is a global concern in mental health units. The limited extant literature exploring the use of structured violence risk assessments in mental health units, although small and inconsistent, reveals some positive impacts on the incidence of aggression and staff's use of restrictive interventions. Although numerous violence risk assessment instruments have been developed and tested, their systematic implementation and use are still limited. A project titled "Safer Working Management" (111298) was conducted in a Finnish hospital district, across 3 mental health units. The 6 steps of OMRU were followed during implementation of the Dynamic Appraisal of Situational Aggression (DASA). Nurses' views toward structured violence risk assessment procedures varied. Although implementation of the DASA was seen as a useful method to increase discussions with patients and nursing staff, some staff preferred their own clinical judgment for assessment of violence risk. It is possible to use a specific model to promote the implementation of risk assessment instruments in mental health units. However, the complex mental health inpatient environment and the difficulties in understanding and managing aggressive patients present challenges for the implementation of structured violence risk assessment methods. The OMRU provides a tool for clinical nurse specialists to guide implementation process in mental health units. Clinical nurse specialists must promote training for staff regarding use of new innovations, such as the DASA. Implementation processes should be reviewed so that clinical nurse specialists can lead and support mental health staff to properly use structured violence risk assessment measures.
Behavioral and Physiological Findings of Gender Differences in Global-Local Visual Processing

ERIC Educational Resources Information Center

Roalf, David; Lowery, Natasha; Turetsky, Bruce I.

2006-01-01

Hemispheric asymmetries in global-local visual processing are well-established, as are gender differences in cognition. Although hemispheric asymmetry presumably underlies gender differences in cognition, the literature on gender differences in global-local processing is sparse. We employed event related brain potential (ERP) recordings during…
Cultural Variations in Global versus Local Processing: A Developmental Perspective

ERIC Educational Resources Information Center

Oishi, Shigehiro; Jaswal, Vikram K.; Lillard, Angeline S.; Mizokawa, Ai; Hitokoto, Hidefumi; Tsutsui, Yoshiro

2014-01-01

We conducted 3 studies to explore cultural differences in global versus local processing and their developmental trajectories. In Study 1 ("N" = 363), we found that Japanese college students were less globally oriented in their processing than American or Argentine participants. We replicated this effect in Study 2 ("N" =…
Discordance between patient and physician assessments of global disease activity in rheumatoid arthritis and association with work productivity.

PubMed

Smolen, Josef S; Strand, Vibeke; Koenig, Andrew S; Szumski, Annette; Kotak, Sameer; Jones, Thomas V

2016-05-21

Discordance between patient and physician ratings of rheumatoid arthritis (RA) severity occurs in clinical practice and correlates with pain scores and measurements of joint disease. However, information is lacking on whether discordance impacts patients' ability to work. We evaluated the discordance between patient and physician ratings of RA disease activity before and after treatment with etanercept and investigated the associations between discordance, clinical outcomes, and work productivity. In the PRESERVE clinical trial, patients with moderate RA received open-label etanercept 50 mg once weekly plus methotrexate for 36 weeks. Baseline and week-36 disease characteristics and clinical and work productivity outcomes were categorized according to week-36 concordance category, defined as positive discordance (patient global assessment - physician global assessment ≥2), negative discordance (patient global assessment - physician global assessment ≤ -2), and concordance (absolute difference between the two disease activity assessments = 0 or 1). Correlations between discordance, clinical outcomes, and predictors of discordance were determined. At baseline, 520/762 (68.2 %) patient and physician global assessment scores were concordant, 194 (25.5 %) were positively discordant, and 48 (6.3 %) were negatively discordant. After 36 weeks of therapy, 556/763 (72.9 %) scores were concordant, 189 (24.8 %) were positively discordant, and 18 (2.4 %) were negatively discordant. Patients with week-36 concordance had the best 36-week clinical and patient-reported outcomes, and overall, the greatest improvement between baseline and week 36. Baseline pain, swollen joint count, duration of morning stiffness, fatigue, and patient general health significantly correlated with week-36 discordance, p < 0.0001 to p < 0.05. Additionally, baseline pain, patient general health, and C-reactive protein were predictors of week-36 discordance (odds ratios 1.22, 1.02, and 0.98, respectively). For the employed patients, percent impairment while working and percent overall work impairment were highest (greatest impairment) at baseline and 36 weeks in the group with positive discordance. The percentage of patients with concordance increased after 36 weeks of treatment with etanercept, with concordant patients demonstrating the greatest improvement in clinical and patient-reported outcomes. Discordance correlated with several measures of disease activity and was associated with decreased work productivity. ClinicalTrials.gov identifier: NCT00565409 . Registered 28/11/2007.
The Internet and Clinical Trials: Background, Online Resources, Examples and Issues

PubMed Central

Seib, Rachael; Prescott, Todd

2005-01-01

Both the Internet and clinical trials were significant developments in the latter half of the twentieth century: the Internet revolutionized global communications and the randomized controlled trial provided a means to conduct an unbiased comparison of two or more treatments. Large multicenter trials are often burdened with an extensive development time and considerable expense, as well as significant challenges in obtaining, backing up and analyzing large amounts of data. Alongside the increasing complexities of the modern clinical trial has grown the power of the Internet to improve communications, centralize and secure data as well as to distribute information. As more and more clinical trials are required to coordinate multiple trial processes in real time, centers are turning to the Internet for the tools to manage the components of a clinical trial, either in whole or in part, to produce lower costs and faster results. This paper reviews the historical development of the Internet and the randomized controlled trial, describes the Internet resources available that can be used in a clinical trial, reviews some examples of online trials and describes the advantages and disadvantages of using the Internet to conduct a clinical trial. We also extract the characteristics of the 5 largest clinical trials conducted using the Internet to date, which together enrolled over 26000 patients. PMID:15829477
The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis.

PubMed

Mollayeva, Tatyana; Thurairajah, Pravheen; Burton, Kirsteen; Mollayeva, Shirin; Shapiro, Colin M; Colantonio, Angela

2016-02-01

This review appraises the process of development and the measurement properties of the Pittsburgh sleep quality index (PSQI), gauging its potential as a screening tool for sleep dysfunction in non-clinical and clinical samples; it also compares non-clinical and clinical populations in terms of PSQI scores. MEDLINE, Embase, PsycINFO, and HAPI databases were searched. Critical appraisal of studies of measurement properties was performed using COSMIN. Of 37 reviewed studies, 22 examined construct validity, 19 - known-group validity, 15 - internal consistency, and three - test-retest reliability. Study quality ranged from poor to excellent, with the majority designated fair. Internal consistency, based on Cronbach's alpha, was good. Discrepancies were observed in factor analytic studies. In non-clinical and clinical samples with known differences in sleep quality, the PSQI global scores and all subscale scores, with the exception of sleep disturbance, differed significantly. The best evidence synthesis for the PSQI showed strong reliability and validity, and moderate structural validity in a variety of samples, suggesting the tool fulfills its intended utility. A taxonometric analysis can contribute to better understanding of sleep dysfunction as either a dichotomous or continuous construct. Copyright © 2015 Elsevier Ltd. All rights reserved.
Strategies in disability management. Corporate disability management programs implemented at the work site.

PubMed

Kalina, C M

1999-10-30

Managers are challenged to demonstrate all programs as economically essential to the business, generating an appreciable return on investment. Further challenge exists to blend and integrate clinical and business objectives in program development. Disability management programs must be viewed as economically essential to the financial success of the business to assure management support for clinical interventions and return-to-work strategies essential for a successful program. This paper discusses a disability management program integrating clinical and business goals and objectives in return-to-work strategies to effect positive clinical, social-cultural, and business results. Clinical, educational, social, and economic challenges in the development, implementation, and continued management of a disability program at a large corporation with multiple global work sites are defined. Continued discussion addresses the effective clinical interventions and educational strategies utilized successfully within the workplace environment in response to each defined challenge. A multiple disciplinary team approach, clinical and business outcome measures, and quality assurance indicators are discussed as major program components. This article discusses a successful program approach focusing on business process and methodology. These parameters are used to link resources to strategy, developing a product for implementing and managing a program demonstrating economic value added through effective clinical medical case management.
Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical research.

PubMed

Julé, Amélie; Furtado, Tamzin; Boggs, Liam; van Loggerenberg, Francois; Ewing, Victoria; Vahedi, Manhaz; Launois, Pascal; Lang, Trudie

2017-01-01

Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas-(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally.

Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical research

PubMed Central

Julé, Amélie; Boggs, Liam; van Loggerenberg, Francois; Ewing, Victoria; Vahedi, Manhaz; Launois, Pascal; Lang, Trudie

2017-01-01

Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas—(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally. PMID:28589027
A machine learning based approach to identify protected health information in Chinese clinical text.

PubMed

Du, Liting; Xia, Chenxi; Deng, Zhaohua; Lu, Gary; Xia, Shuxu; Ma, Jingdong

2018-08-01

With the increasing application of electronic health records (EHRs) in the world, protecting private information in clinical text has drawn extensive attention from healthcare providers to researchers. De-identification, the process of identifying and removing protected health information (PHI) from clinical text, has been central to the discourse on medical privacy since 2006. While de-identification is becoming the global norm for handling medical records, there is a paucity of studies on its application on Chinese clinical text. Without efficient and effective privacy protection algorithms in place, the use of indispensable clinical information would be confined. We aimed to (i) describe the current process for PHI in China, (ii) propose a machine learning based approach to identify PHI in Chinese clinical text, and (iii) validate the effectiveness of the machine learning algorithm for de-identification in Chinese clinical text. Based on 14,719 discharge summaries from regional health centers in Ya'an City, Sichuan province, China, we built a conditional random fields (CRF) model to identify PHI in clinical text, and then used the regular expressions to optimize the recognition results of the PHI categories with fewer samples. We constructed a Chinese clinical text corpus with PHI tags through substantial manual annotation, wherein the descriptive statistics of PHI manifested its wide range and diverse categories. The evaluation showed with a high F-measure of 0.9878 that our CRF-based model had a good performance for identifying PHI in Chinese clinical text. The rapid adoption of EHR in the health sector has created an urgent need for tools that can parse patient specific information from Chinese clinical text. Our application of CRF algorithms for de-identification has shown the potential to meet this need by offering a highly accurate and flexible solution to analyzing Chinese clinical text. Copyright © 2018 Elsevier B.V. All rights reserved.
Seeing the Forest "and" the Trees: Default Local Processing in Individuals with High Autistic Traits Does Not Come at the Expense of Global Attention

ERIC Educational Resources Information Center

Stevenson, Ryan A.; Sun, Sol Z.; Hazlett, Naomi; Cant, Jonathan S.; Barense, Morgan D.; Ferber, Susanne

2018-01-01

Atypical sensory perception is one of the most ubiquitous symptoms of autism, including a tendency towards a local-processing bias. We investigated whether local-processing biases were associated with global-processing impairments on a global/local attentional-scope paradigm in conjunction with a composite-face task. Behavioural results were…
Global health diplomacy in Iraq: international relations outcomes of multilateral tuberculosis programmes.

PubMed

Kevany, Sebastian; Jaf, Payman; Workneh, Nibretie Gobezie; Abu Dalod, Mohammad; Tabena, Mohammed; Rashid, Sara; Al Hilfi, Thamer Kadum Yousif

2014-01-01

International development programmes, including global health interventions, have the capacity to make important implicit and explicit benefits to diplomatic and international relations outcomes. Conversely, in the absence of awareness of these implications, such programmes may generate associated threats. Due to heightened international tensions in conflict and post-conflict settings, greater attention to diplomatic outcomes may therefore be necessary. We examine related 'collateral' effects of Global Fund-supported tuberculosis programmes in Iraq. During site visits to Iraq conducted during 2012 and 2013 on behalf of the Global Fund to Fight AIDS, Tuberculosis and Malaria, on-site service delivery evaluations, unstructured interviews with clinical and operational staff, and programme documentary review of Global Fund-supported tuberculosis treatment and care programmes were conducted. During this process, a range of possible external or collateral international relations and diplomatic effects of global health programmes were assessed according to predetermined criteria. A range of positive diplomatic and international relations effects of Global Fund-supported programmes were observed in the Iraq setting. These included (1) geo-strategic accessibility and coverage; (2) provisions for programme sustainability and alignment; (3) contributions to nation-building and peace-keeping initiatives; (4) consistent observation of social, cultural and religious norms in intervention selection; and (5) selection of the most effective and cost-effective tuberculosis treatment and care interventions. Investments in global health programmes have valuable diplomatic, as well as health-related, outcomes, associated with their potential to prevent, mitigate or reverse international tension and hostility in conflict and post-conflict settings, provided that they adhere to appropriate criteria. The associated international presence in such regions may also contribute to peace-keeping efforts. Global health programmes may frequently produce a wider range of 'collateral benefits' that conventional monitoring and evaluation systems should be expanded to assess, in keeping with contemporary efforts to leverage development programmes from a 'global health diplomacy' perspective.
US medical specialty global health training and the global burden of disease

PubMed Central

Kerry, Vanessa B.; Walensky, Rochelle P.; Tsai, Alexander C.; Bergmark, Regan W.; Bergmark, Brian A.; Rouse, Chaturia; Bangsberg, David R.

2013-01-01

Background Rapid growth in global health activity among US medical specialty education programs has lead to heterogeneity in types of activities and global health training models. The breadth and scope of this activity is not well chronicled. Methods Using a standardized search protocol, we examined the characteristics of US medical residency global health programs by number of programs, clinical specialty, nature of activity (elective, research, extended curriculum based field training), and geographic location across seven different clinical medical residency education specialties. We tabulated programmatic activity by clinical discipline, region and country. We calculated the Spearman's rank correlation coefficient to estimate the association between programmatic activity and country–level disease burden. Results Of the 1856 programs assessed between January and June 2011, there were 380 global health residency training programs (20%) working in 141 countries. 529 individual programmatic activities (elective–based rotations, research programs, extended curriculum–based field training, or other) occurred at 1337 specific sites. The majority of the activities consisted of elective–based rotations. At the country level, disease burden had a statistically significant association with programmatic activity (Spearman's ρ = 0.17) but only explained 3% of the total variation between countries. Conclusions There were a substantial number of US medical specialty global health programs, but a relative paucity of surgical and mental health programs. Elective–based programs were more common than programs that offer longitudinal experiences. Despite heterogeneity, there was a small but statistically significant association between program location and the global burden of disease. Areas for further study include the degree to which US–based programs develop partnerships with their program sites, the significance of this activity for training, and number and breadth of programs in medical specialty global health education in other countries around the world. PMID:24363924
Priming global and local processing of composite faces: revisiting the processing-bias effect on face perception.

PubMed

Gao, Zaifeng; Flevaris, Anastasia V; Robertson, Lynn C; Bentin, Shlomo

2011-07-01

We used the composite-face illusion and Navon stimuli to determine the consequences of priming local or global processing on subsequent face recognition. The composite-face illusion reflects the difficulty of ignoring the task-irrelevant half-face while attending the task-relevant half if the half-faces in the composite are aligned. On each trial, participants first matched two Navon stimuli, attending to either the global or the local level, and then matched the upper halves of two composite faces presented sequentially. Global processing of Navon stimuli increased the sensitivity to incongruence between the upper and the lower halves of the composite face, relative to a baseline in which the composite faces were not primed. Local processing of Navon stimuli did not influence the sensitivity to incongruence. Although incongruence induced a bias toward different responses, this bias was not modulated by priming. We conclude that global processing of Navon stimuli augments holistic processing of the face.
The Global in Global Health is Not a Given

PubMed Central

Mason, Paul H.; Kerridge, Ian; Lipworth, Wendy

2017-01-01

The process of globalization is commonly espoused as a means for promoting global health. Efforts to “go global” can, however, easily go awry as a result of lack of attention to local social, economic, and political contexts and/or as a result of commercial and political imperatives that allow local populations to be exploited. Critical analysis of the processes of globalization is necessary to better understand the local particularities of global projects and confront challenges more transparently. We illustrate the potential adverse impacts of globalization in the global health setting, through examination of international tuberculosis control, global mental health, and the establishment of transnational biobank networks. PMID:28138044
Postapproval Development Options in COPD: A Case Study in Value-Based Healthcare Systems.

PubMed

Murphy, Michael F; Antonini, Paola; Lai, Zhihong Vicki

2011-01-01

Research and development activities in an era of globalization encounter a mosaic of providers, products, services, and intermediaries; regulatory and other government institutions; and consumers. The introduction of novel therapeutics into this environment mandates research programs that are relevant to the registration process, payers and purchasers, transparent pricing, and rule-driven business practices, while providing data relevant to marketing initiatives internationally. To outline an example for clinical development programs that incorporate the perspective of multiple stakeholders into a portfolio of study designs to provide optimal data platforms that can resonate with diverse recipients. A contract research organization directly involved in the design, execution, and analysis of clinical trials for new drugs and devices across pharmaceutical and biotechnology companies provides a unique perspective regarding opportunities and challenges within the international clinical research environment. Drs Murphy, Antonini, and Lai, representing Worldwide Clinical Trials, utilize chronic obstructive pulmonary disease as a demonstration project exploiting its prevalence, direct and indirect costs, and the rapid infusion/diffusion of innovative therapy into practice as a rationale for focus, and illustrate methods of informing registration and technology assessments during a prototypical development process. By virtue of its chronicity, prevalence, and pattern of healthcare utilization, chronic obstructive pulmonary disease provides an ideal case for illustrating the application of clinical trial methodology that can facilitate data evaluation through the prism of multiple stakeholders. Adding an international dimension exacerbates system complexity and serves to illustrate the breadth of issues that can be addressed within this therapeutic area.
Multidimensional electrostatic repulsion-hydrophilic interaction chromatography (ERLIC) for quantitative analysis of the proteome and phosphoproteome in clinical and biomedical research.

PubMed

Loroch, Stefan; Schommartz, Tim; Brune, Wolfram; Zahedi, René Peiman; Sickmann, Albert

2015-05-01

Quantitative proteomics and phosphoproteomics have become key disciplines in understanding cellular processes. Fundamental research can be done using cell culture providing researchers with virtually infinite sample amounts. In contrast, clinical, pre-clinical and biomedical research is often restricted to minute sample amounts and requires an efficient analysis with only micrograms of protein. To address this issue, we generated a highly sensitive workflow for combined LC-MS-based quantitative proteomics and phosphoproteomics by refining an ERLIC-based 2D phosphoproteomics workflow into an ERLIC-based 3D workflow covering the global proteome as well. The resulting 3D strategy was successfully used for an in-depth quantitative analysis of both, the proteome and the phosphoproteome of murine cytomegalovirus-infected mouse fibroblasts, a model system for host cell manipulation by a virus. In a 2-plex SILAC experiment with 150 μg of a tryptic digest per condition, the 3D strategy enabled the quantification of ~75% more proteins and even ~134% more peptides compared to the 2D strategy. Additionally, we could quantify ~50% more phosphoproteins by non-phosphorylated peptides, concurrently yielding insights into changes on the levels of protein expression and phosphorylation. Beside its sensitivity, our novel three-dimensional ERLIC-strategy has the potential for semi-automated sample processing rendering it a suitable future perspective for clinical, pre-clinical and biomedical research. Copyright © 2015. Published by Elsevier B.V.
High-Throughput Analysis of Global DNA Methylation Using Methyl-Sensitive Digestion.

PubMed

Shiratori, Hiromi; Feinweber, Carmen; Knothe, Claudia; Lötsch, Jörn; Thomas, Dominique; Geisslinger, Gerd; Parnham, Michael J; Resch, Eduard

2016-01-01

DNA methylation is a major regulatory process of gene transcription, and aberrant DNA methylation is associated with various diseases including cancer. Many compounds have been reported to modify DNA methylation states. Despite increasing interest in the clinical application of drugs with epigenetic effects, and the use of diagnostic markers for genome-wide hypomethylation in cancer, large-scale screening systems to measure the effects of drugs on DNA methylation are limited. In this study, we improved the previously established fluorescence polarization-based global DNA methylation assay so that it is more suitable for application to human genomic DNA. Our methyl-sensitive fluorescence polarization (MSFP) assay was highly repeatable (inter-assay coefficient of variation = 1.5%) and accurate (r2 = 0.99). According to signal linearity, only 50-80 ng human genomic DNA per reaction was necessary for the 384-well format. MSFP is a simple, rapid approach as all biochemical reactions and final detection can be performed in one well in a 384-well plate without purification steps in less than 3.5 hours. Furthermore, we demonstrated a significant correlation between MSFP and the LINE-1 pyrosequencing assay, a widely used global DNA methylation assay. MSFP can be applied for the pre-screening of compounds that influence global DNA methylation states and also for the diagnosis of certain types of cancer.
Parents' global rating of mental health correlates with SF-36 scores and health services satisfaction.

PubMed

Mah, Jean K; Tough, Suzanne; Fung, Thomas; Douglas-England, Kathleen; Verhoef, Marja

2006-10-01

Patient satisfaction surveys are often used to measure quality of care. However, patient satisfaction may not be a reliable indicator of service quality because satisfaction can be influenced by clients' characteristics such as their health status. Parents of children attending a pediatric neurology clinic completed the Short Form Health Survey (SF-36) and global ratings of their physical and mental health. They also completed the Client Satisfaction Questionnaire (CSQ), the Measure of Processes of Care (MPOC), and the Family-Centered Care Survey (FCCS). 104 parents completed the survey. The correlation between the global rating of physical or mental health and their corresponding SF-36 scores was high. The majority (88%) of parents were satisfied, with a median CSQ score of 28 (IQR, 24 to 31) and a FCCS score of 4.7 (IQR, 4.2 to 4.9). Logistic regression identified parents' mental health as a significant predictor of client satisfaction (OR, 1.07; 95% CI, 1.01 to 1.14). Given the positive association between parents' mental health and satisfaction with care, it is important to consider mental status as a covariate in interpreting satisfaction surveys. Parents' global rating of mental health appears to be a reasonable indicator of their SF-36 mental scores.
Phasic alertness enhances processing of face and non-face stimuli in congenital prosopagnosia.

PubMed

Tanzer, Michal; Weinbach, Noam; Mardo, Elite; Henik, Avishai; Avidan, Galia

2016-08-01

Congenital prosopagnosia (CP) is a severe face processing impairment that occurs in the absence of any obvious brain damage and has often been associated with a more general deficit in deriving holistic relations between facial features or even between non-face shape dimensions. Here we further characterized this deficit and examined a potential way to ameliorate it. To this end we manipulated phasic alertness using alerting cues previously shown to modulate attention and enhance global processing of visual stimuli in normal observers. Specifically, we first examined whether individuals with CP, similarly to controls, would show greater global processing when exposed to an alerting cue in the context of a non-facial task (Navon global/local task). We then explored the effect of an alerting cue on face processing (upright/inverted face discrimination). Confirming previous findings, in the absence of alerting cues, controls showed a typical global bias in the Navon task and an inversion effect indexing holistic processing in the upright/inverted task, while CP failed to show these effects. Critically, when alerting cues preceded the experimental trials, both groups showed enhanced global interference and a larger inversion effect. These results suggest that phasic alertness may modulate visual processing and consequently, affect global/holistic perception. Hence, these findings further reinforce the notion that global/holistic processing may serve as a possible mechanism underlying the face processing deficit in CP. Moreover, they imply a possible route for enhancing face processing in individuals with CP and thus shed new light on potential amelioration of this disorder. Copyright © 2016 Elsevier Ltd. All rights reserved.
Virtual patients in a real clinical context using augmented reality: impact on antibiotics prescription behaviors.

PubMed

Nifakos, Sokratis; Zary, Nabil

2014-01-01

The research community has called for the development of effective educational interventions for addressing prescription behaviour since antimicrobial resistance remains a global health issue. Examining the potential to displace the educational process from Personal Computers to Mobile devices, in this paper we investigated a new method of integration of Virtual Patients into Mobile devices with augmented reality technology, enriching the practitioner's education in prescription behavior. Moreover, we also explored which information are critical during the prescription behavior education and we visualized these information on real context with augmented reality technology, simultaneously with a running Virtual Patient's scenario. Following this process, we set the educational frame of experiential knowledge to a mixed (virtual and real) environment.
Process for Mapping Global Health Competencies in Undergraduate and Graduate Nursing Curricula.

PubMed

Dawson, Martha; Gakumo, C Ann; Phillips, Jennan; Wilson, Lynda

2016-01-01

Determining the extent to which existing nursing curricula prepare students to address global health issues is a critical step toward ensuring competence to practice in an increasingly globalized world. This article describes the process used by nursing faculty at a public university in the southern United States to assess the extent to which global health competencies for nurses were being addressed across nursing programs. Steps used and lessons learned throughout this process are discussed.
The World Health Organization Global Health Emergency Workforce: What Role Will the United States Play?

PubMed

Burkle, Frederick M

2016-08-01

During the May 2016 World Health Assembly of 194 member states, the World Health Organization (WHO) announced the process of developing and launching emergency medical teams as a critical component of the global health workforce concept. Over 64 countries have either launched or are in the development stages of vetting accredited teams, both international and national, to provide surge support to national health systems through WHO Regional Organizations and the delivery of emergency clinical care to sudden-onset disasters and outbreak-affected populations. To date, the United States has not yet committed to adopting the emergency medical team concept in funding and registering an international field hospital level team. This article discusses future options available for health-related nongovernmental organizations and the required educational and training requirements for health care provider accreditation. (Disaster Med Public Health Preparedness. 2016;10:531-535).
Integrating heterogeneous databases in clustered medic care environments using object-oriented technology

NASA Astrophysics Data System (ADS)

Thakore, Arun K.; Sauer, Frank

1994-05-01

The organization of modern medical care environments into disease-related clusters, such as a cancer center, a diabetes clinic, etc., has the side-effect of introducing multiple heterogeneous databases, often containing similar information, within the same organization. This heterogeneity fosters incompatibility and prevents the effective sharing of data amongst applications at different sites. Although integration of heterogeneous databases is now feasible, in the medical arena this is often an ad hoc process, not founded on proven database technology or formal methods. In this paper we illustrate the use of a high-level object- oriented semantic association method to model information found in different databases into an integrated conceptual global model that integrates the databases. We provide examples from the medical domain to illustrate an integration approach resulting in a consistent global view, without attacking the autonomy of the underlying databases.
Herbal medicine research and global health: an ethical analysis.

PubMed

Tilburt, Jon C; Kaptchuk, Ted J

2008-08-01

Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal medicine research: social value, scientific validity and favourable risk-benefit ratio. Significant challenges exist in determining shared concepts of social value, scientific validity and favourable risk-benefit ratio across international research collaborations. However, we argue that collaborative partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international herbal medicine research can, and should be, resolved. By "cross-training" investigators, and investing in safety-monitoring infrastructure, the issues identified by this comprehensive framework can promote ethically sound international herbal medicine research that contributes to global health.
[Establishing the acupuncture-moxibustion clinical trial registry and improving the transparence of clinical trials of acupuncture and moxibustion].

PubMed

Liu, Yali; He, Liyun; Liu, Jia; Yang, Xingyue; Yan, Dongning; Wang, Xin; Luo, Lin; Li, Hongjiao; Yan, Shiyan; Wen, Tiancai; Bai, Wenjing; Wu, Taixiang; Liu, Baoyan

2017-07-12

As a kind of intervention measures of traditional Chinese medicine, acupuncture-moxibustion is highly adopted on global clinical practice. Even though the global clinical trial registration system was established more than 10 years ago, the proportion of acupuncture-moxibustion clinical trial registration is still very low; and it is very problematic on the methodological quality and report quality in the published acupuncture-moxibustion clinical trials. In order to manage particularly the acupuncture-moxibustion clinical trials, China Academy of Chinese Medical Sciences, collaborated with China Association of Acupuncture and Moxibustion and World Federation of Acupuncture Societies, established the Acupuncture-Moxibustion Clinical Trail Registry (AMCTR). AMCTR is a secondary registry platform affiliated to the Chinese Clinical Trial Registry (ChiCTR) and WHO International Clinical Trials Registry Platform (ICTRP), specifically for the acceptance and management of clinical trials in the field of acupuncture and moxibustion. It is a nonprofit academic organization, located in China Academy of Chinese Medical Sciences.
Initial strides for invent-VTE: Towards global collaboration to accelerate clinical research in venous thromboembolism.

PubMed

Rodger, Marc; Langlois, Nicole; Middeldorp, Saskia; Kahn, Susan; Sandset, Per Morten; Brighton, Timothy; Huisman, Menno V; Meyer, Guy; Konstantinides, Stavros; Ageno, Walter; Morange, Pierre; Garcia, David; Kreuziger, Lisa Baumann; Young, Laura; Key, Nigel; Monreal, Manuel; Jiménez, David

2018-03-01

Venous thromboembolism (VTE) represents a major global burden of disease and requires collaborative efforts to conduct large, high-quality investigator-initiated and academically sponsored studies addressing the most relevant clinical questions. Owing to increasing regulatory requirements, the highly competitive nature of peer-reviewed funding and costs associated with conducting large, multinational clinical trials, completing practice-changing research constitutes a growing challenge for clinical investigators. As clinical trialists interested in VTE, we founded INVENT (International Network of Venous Thromboembolism Clinical Research Networks) in an effort to promote and accelerate patient-oriented, investigator-initiated, international collaborative research, to identify, prioritize and answer key clinical research questions for patients with VTE. We report on our activities to formalize the INVENT network and our accomplishments in our first year. Copyright © 2018 Elsevier Ltd. All rights reserved.
Effects of global and local contexts on chord processing: An ERP study.

PubMed

Zhang, Jingjing; Zhou, Xuefeng; Chang, Ruohan; Yang, Yufang

2018-01-31

In real life, the processing of an incoming event is continuously influenced by prior information at multiple timescales. The present study investigated how harmonic contexts at both local and global levels influence the processing of an incoming chord in an event-related potentials experiment. Chord sequences containing two phrases were presented to musically trained listeners, with the last critical chord either harmonically related or less related to its preceding context at local and/or global levels. ERPs data showed an ERAN-like effect for local context in early time window and a N5-like component for later interaction between the local context and global context. These results suggest that both the local and global contexts influence the processing of an incoming music event, and the local effect happens earlier than the global. Moreover, the interaction between the local context and global context in N5 may suggest that music syntactic integration at local level takes place prior to the integration at global level. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings

PubMed Central

Yeates, Karen; Perkins, Nancy; Boesch, Lisa; Hua-Stewart, Diane; Liu, Peter; Sleeth, Jessica; Tobe, Sheldon W

2017-01-01

Background To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. Objective Building on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension—Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. Methods Our literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. Results Four human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. Conclusions Using DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. Trial Registration ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege) PMID:28428165
Direct effects of diazepam on emotional processing in healthy volunteers

PubMed Central

Murphy, S. E.; Downham, C.; Cowen, P. J.

2008-01-01

Rationale Pharmacological agents used in the treatment of anxiety have been reported to decrease threat relevant processing in patients and healthy controls, suggesting a potentially relevant mechanism of action. However, the effects of the anxiolytic diazepam have typically been examined at sedative doses, which do not allow the direct actions on emotional processing to be fully separated from global effects of the drug on cognition and alertness. Objectives The aim of this study was to investigate the effect of a lower, but still clinically effective, dose of diazepam on emotional processing in healthy volunteers. Materials and methods Twenty-four participants were randomised to receive a single dose of diazepam (5 mg) or placebo. Sixty minutes later, participants completed a battery of psychological tests, including measures of non-emotional cognitive performance (reaction time and sustained attention) and emotional processing (affective modulation of the startle reflex, attentional dot probe, facial expression recognition, and emotional memory). Mood and subjective experience were also measured. Results Diazepam significantly modulated attentional vigilance to masked emotional faces and significantly decreased overall startle reactivity. Diazepam did not significantly affect mood, alertness, response times, facial expression recognition, or sustained attention. Conclusions At non-sedating doses, diazepam produces effects on attentional vigilance and startle responsivity that are consistent with its anxiolytic action. This may be an underlying mechanism through which benzodiazepines exert their therapeutic effects in clinical anxiety. PMID:18581100
Promoting Simulation Globally: Networking with Nursing Colleagues Across Five Continents.

PubMed

Alfes, Celeste M; Madigan, Elizabeth A

Simulation education is gaining momentum internationally and may provide the opportunity to enhance clinical education while disseminating evidence-based practice standards for clinical simulation and learning. There is a need to develop a cohesive leadership group that fosters support, networking, and sharing of simulation resources globally. The Frances Payne Bolton School of Nursing at Case Western Reserve University has had the unique opportunity to establish academic exchange programs with schools of nursing across five continents. Although the joint and mutual simulation activities have been extensive, each international collaboration has also provided insight into the innovations developed by global partners.
Measuring the impact of final demand on global production system based on Markov process

NASA Astrophysics Data System (ADS)

Xing, Lizhi; Guan, Jun; Wu, Shan

2018-07-01

Input-output table is a comprehensive and detailed in describing the national economic systems, consisting of supply and demand information among various industrial sectors. The complex network, a theory and method for measuring the structure of complex system, can depict the structural properties of social and economic systems, and reveal the complicated relationships between the inner hierarchies and the external macroeconomic functions. This paper tried to measure the globalization degree of industrial sectors on the global value chain. Firstly, it constructed inter-country input-output network models to reproduce the topological structure of global economic system. Secondly, it regarded the propagation of intermediate goods on the global value chain as Markov process and introduced counting first passage betweenness to quantify the added processing amount when globally final demand stimulates this production system. Thirdly, it analyzed the features of globalization at both global and country-sector level
Systems Factorial Technology provides new insights on global-local information processing in autism spectrum disorders.

PubMed

Johnson, Shannon A; Blaha, Leslie M; Houpt, Joseph W; Townsend, James T

2010-02-01

Previous studies of global-local processing in autism spectrum disorders (ASDs) have indicated mixed findings, with some evidence of a local processing bias, or preference for detail-level information, and other results suggesting typical global advantage, or preference for the whole or gestalt. Findings resulting from this paradigm have been used to argue for or against a detail focused processing bias in ASDs, and thus have important theoretical implications. We applied Systems Factorial Technology, and the associated Double Factorial Paradigm (both defined in the text), to examine information processing characteristics during a divided attention global-local task in high-functioning individuals with an ASD and typically developing controls. Group data revealed global advantage for both groups, contrary to some current theories of ASDs. Information processing models applied to each participant revealed that task performance, although showing no differences at the group level, was supported by different cognitive mechanisms in ASD participants compared to controls. All control participants demonstrated inhibitory parallel processing and the majority demonstrated a minimum-time stopping rule. In contrast, ASD participants showed exhaustive parallel processing with mild facilitatory interactions between global and local information. Thus our results indicate fundamental differences in the stopping rules and channel dependencies in individuals with an ASD.
A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: Many options, no standards.

PubMed

Futamura, Masaki; Leshem, Yael A; Thomas, Kim S; Nankervis, Helen; Williams, Hywel C; Simpson, Eric L

2016-02-01

Investigators often use global assessments to provide a snapshot of overall disease severity in dermatologic clinical trials. Although easy to perform, the frequency of use and standardization of global assessments in studies of atopic dermatitis (AD) is unclear. We sought to assess the frequency, definitions, and methods of analysis of Investigator Global Assessment in randomized controlled trials of AD. We conducted a systematic review using all published randomized controlled trials of AD treatments in the Global Resource of Eczema Trials database (2000-2014). We determined the frequency of global scales application and defining features. Among 317 trials identified, 101 trials (32%) used an investigator-performed global assessment as an outcome measure. There was large variability in global assessments between studies in nomenclature, scale size, definitions, outcome description, and analysis. Both static and dynamic scales were identified that ranged from 4- to 7-point scales. North American studies used global assessments more commonly than studies from other countries. The search was restricted to the Global Resource of Eczema Trials database. Global assessments are used frequently in studies of AD, but their complete lack of standardized definitions and implementation preclude any meaningful comparisons between studies, which in turn impedes data synthesis to inform clinical decision-making. Standardization is urgently required. Copyright © 2015. Published by Elsevier Inc.
The Importance of Global Health Experiences in the Development of New Cardiologists.

PubMed

Abdalla, Marwah; Kovach, Neal; Liu, Connie; Damp, Julie B; Jahangir, Eiman; Hilliard, Anthony; Gopinathannair, Rakesh; Abu-Fadel, Mazen S; El Chami, Mikhael F; Gafoor, Sameer; Vedanthan, Rajesh; Sanchez-Shields, Monica; George, Jon C; Priester, Tiffany; Alasnag, Mirvat; Barker, Colin; Freeman, Andrew M

2016-06-14

As the global burden of cardiovascular disease continues to increase worldwide, nurturing the development of early-career cardiologists interested in global health is essential to create a cadre of providers with the skill set to prevent and treat cardiovascular diseases in international settings. As such, interest in global health has increased among cardiology trainees and early-career cardiologists over the past decade. International clinical and research experiences abroad present an additional opportunity for growth and development beyond traditional cardiovascular training. We describe the American College of Cardiology International Cardiovascular Exchange Database, a new resource for cardiologists interested in pursuing short-term clinical exchange opportunities abroad, and report some of the benefits and challenges of global health cardiovascular training in both resource-limited and resource-abundant settings. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Cultural variations in global versus local processing: a developmental perspective.

PubMed

Oishi, Shigehiro; Jaswal, Vikram K; Lillard, Angeline S; Mizokawa, Ai; Hitokoto, Hidefumi; Tsutsui, Yoshiro

2014-12-01

We conducted 3 studies to explore cultural differences in global versus local processing and their developmental trajectories. In Study 1 (N = 363), we found that Japanese college students were less globally oriented in their processing than American or Argentine participants. We replicated this effect in Study 2 (N = 1,843) using a nationally representative sample of Japanese and American adults ages 20 to 69, and found further that adults in both cultures became more globally oriented with age. In Study 3 (N = 133), we investigated the developmental course of the cultural difference using Japanese and American children, and found it was evident by 4 years of age. Cultural variations in global versus local processing emerge by early childhood, and remain throughout adulthood. At the same time, both Japanese and Americans become increasingly global processors with age. PsycINFO Database Record (c) 2014 APA, all rights reserved.
Outcome at two years after dextrose gel treatment for neonatal hypoglycemia; Follow up of a randomized trial

PubMed Central

Harris, Deborah L; Alsweiler, Jane M; Ansell, Judith M; Gamble, Greg D; Thompson, Ben; Wouldes, Trecia A; Yu, Tzu-Ying; Harding, Jane E

2015-01-01

Objective To determine neurodevelopmental outcome at two years’ corrected age in children randomized to treatment with dextrose gel or placebo for hypoglycemia soon after birth (The Sugar Babies Study). Study design This was a follow-up study of 184 children who had been hypoglycemic (< 2.6mM [45 mg/dL]) in the first 48 hours and randomized to either dextrose (90/118, 76%) or placebo gel (94/119, 79%). Assessments were performed at Kahikatea House, Hamilton, New Zealand, and included neurological function and general health (Pediatrician assessed), cognitive, language, behaviour and motor skills (Bayley-III), executive function (clinical assessment and BRIEF-P), and vision (clinical examination and global motion perception). Co-primary outcomes were neurosensory impairment (cognitive, language or motor score below −1 SD or cerebral palsy or blind or deaf) and processing difficulty (executive function or global motion perception worse than 1.5 SD from the mean). Statistical tests were two sided with 5% significance level. Results Mean (±SD) birth weight was 3093 ± 803 g and mean gestation was 37.7 ±1.6 weeks. Sixty-six children (36%) had neurosensory impairment (1 severe, 6 moderate, 59 mild) with similar rates in both groups (dextrose 38% vs. placebo 34%, RR 1.11, 95% CI 0.75–1.63). Processing difficulty was also similar between groups (dextrose 10% vs. placebo 18%, RR 0.52, 95% CI 0.23–1.15). Conclusions Dextrose gel is safe for treatment of neonatal hypoglycemia, but neurosensory impairment is common amongst these children. PMID:26613985
Sperm Chromatin Immaturity Observed in Short Abstinence Ejaculates Affects DNA Integrity and Longevity In Vitro

PubMed Central

Salian, Sujith Raj; Kumar, Dayanidhi; Singh, Vikram Jeet; D’Souza, Fiona; Kalthur, Guruprasad; Kamath, Asha; Adiga, Satish Kumar

2016-01-01

Background The influence of ejaculatory abstinence (EA) on semen parameters and subsequent reproductive outcome is still debatable; hence understanding the impact of EA on sperm structural and functional integrity may provide a valuable information on predicting successful clinical outcome. Objective To understand the influence of EA on sperm chromatin maturity, integrity, longevity and global methylation status. Methods This experimental prospective study included 76 ejaculates from 19 healthy volunteers who provided ejaculates after observing 1, 3, 5 and 7 days of abstinence. Sperm chromatin maturity, DNA integrity and global methylation status were assessed in the neat ejaculate. Sperm motility, DNA integrity and longevity were assessed in the processed fraction of the fresh and frozen-thawed ejaculates to determine their association with the length of EA. Results Spermatozoa from 1 day ejaculatory abstinence (EA-1) displayed significantly higher level of sperm chromatin immaturity in comparison to EA-3 (P < 0.05) and EA-5 (P < 0.01) whereas; the number of 5-methyl cytosine immunostained spermatozoa did not vary significantly across groups. On the other hand, in vitro incubation of processed ejaculate from EA-1 resulted in approximately 20 and 40 fold increase in the DNA fragmented spermatozoa at the end of 6 and 24h respectively (P < 0.01–0.001). Conclusion Use of short-term EA for therapeutic fertilization would be a clinically valuable strategy to improve the DNA quality. However, use of such spermatozoa after prolonged incubation in vitro should be avoided as it can carry a substantial risk of transmitting DNA fragmentation to the oocytes. PMID:27043437
Reflections on the Process of Bilingual Education in Latin America: A Perspective from Globalization

ERIC Educational Resources Information Center

Joya, Magdalena; Cerón, Alejandra

2013-01-01

This paper intends to explain how education can be understood as a process that involves the transmission of culture, knowledge, manners and values; meanwhile, globalization implies an evolving process of constructing a global system of languages. In this way, the relationship between the educational and economic systems can become stronger…
White Matter Atrophy and Cognitive Dysfunctions in Neuromyelitis Optica

PubMed Central

Blanc, Frederic; Noblet, Vincent; Jung, Barbara; Rousseau, François; Renard, Felix; Bourre, Bertrand; Longato, Nadine; Cremel, Nadjette; Di Bitonto, Laure; Kleitz, Catherine; Collongues, Nicolas; Foucher, Jack; Kremer, Stephane; Armspach, Jean-Paul; de Seze, Jerome

2012-01-01

Neuromyelitis optica (NMO) is an inflammatory disease of central nervous system characterized by optic neuritis and longitudinally extensive acute transverse myelitis. NMO patients have cognitive dysfunctions but other clinical symptoms of brain origin are rare. In the present study, we aimed to investigate cognitive functions and brain volume in NMO. The study population consisted of 28 patients with NMO and 28 healthy control subjects matched for age, sex and educational level. We applied a French translation of the Brief Repeatable Battery (BRB-N) to the NMO patients. Using SIENAx for global brain volume (Grey Matter, GM; White Matter, WM; and whole brain) and VBM for focal brain volume (GM and WM), NMO patients and controls were compared. Voxel-level correlations between diminished brain concentration and cognitive performance for each tests were performed. Focal and global brain volume of NMO patients with and without cognitive impairment were also compared. Fifteen NMO patients (54%) had cognitive impairment with memory, executive function, attention and speed of information processing deficits. Global and focal brain atrophy of WM but not Grey Matter (GM) was found in the NMO patients group. The focal WM atrophy included the optic chiasm, pons, cerebellum, the corpus callosum and parts of the frontal, temporal and parietal lobes, including superior longitudinal fascicle. Visual memory, verbal memory, speed of information processing, short-term memory and executive functions were correlated to focal WM volumes. The comparison of patients with, to patients without cognitive impairment showed a clear decrease of global and focal WM, including brainstem, corticospinal tracts, corpus callosum but also superior and inferior longitudinal fascicles. Cognitive impairment in NMO patients is correlated to the decreased of global and focal WM volume of the brain. Further studies are needed to better understand the precise origin of cognitive impairment in NMO patients, particularly in the WM. PMID:22509264
Benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study: protocol, tools, and population.

PubMed

Nicolucci, Antonio; Rossi, Maria C; Pellegrini, Fabio; Lucisano, Giuseppe; Pintaudi, Basilio; Gentile, Sandro; Marra, Giampiero; Skovlund, Soren E; Vespasiani, Giacomo

2014-01-01

In the context of the DAWN-2 initiatives, the BENCH-D Study aims to test a model of regional benchmarking to improve not only the quality of diabetes care, but also patient-centred outcomes. As part of the AMD-Annals quality improvement program, 32 diabetes clinics in 4 Italian regions extracted clinical data from electronic databases for measuring process and outcome quality indicators. A random sample of patients with type 2 diabetes filled in a questionnaire including validated instruments to assess patient-centred indicators: SF-12 Health Survey, WHO-5 Well-Being Index, Diabetes Empowerment Scale, Problem Areas in Diabetes, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Barriers to Medications, Patient Support, Diabetes Self-care Activities, and Global Satisfaction for Diabetes Treatment. Data were discussed with participants in regional meetings. Main problems, obstacles and solutions were identified through a standardized process, and a regional mandate was produced to drive the priority actions. Overall, clinical indicators on 78,854 patients have been measured; additionally, 2,390 patients filled-in the questionnaire. The regional mandates were officially launched in March 2012. Clinical and patient-centred indicators will be evaluated again after 18 months. A final assessment of clinical indicators will take place after 30 months. In the context of the BENCH-D study, a set of instruments has been validated to measure patient well-being and satisfaction with the care. In the four regional meetings, different priorities were identified, reflecting different organizational resources of the different areas. In all the regions, a major challenge was represented by the need of skills and instruments to address psychosocial issues of people with diabetes. The BENCH-D study allows a field testing of benchmarking activities focused on clinical and patient-centred indicators.
The effect of sugar and processed food imports on the prevalence of overweight and obesity in 172 countries.

PubMed

Lin, Tracy Kuo; Teymourian, Yasmin; Tursini, Maitri Shila

2018-04-14

Studies find that economic, political, and social globalization - as well as trade liberalization specifically - influence the prevalence of overweight and obesity in countries through increasing the availability and affordability of unhealthful food. However, what are the mechanisms that connect globalization, trade liberalization, and rising average body mass index (BMI)? We suggest that the various sub-components of globalization interact, leading individuals in countries that experience higher levels of globalization to prefer, import, and consume more imported sugar and processed food products than individuals in countries that experience lower levels of globalization. This study codes the amount of sugar and processed food imports in 172 countries from 1995 to 2010 using the United Nations Comtrade dataset. We employ country-specific fixed effects (FE) models, with robust standard errors, to examine the relationship between sugar and processed foods imports, globalization, and average BMI. To highlight further the relationship between the sugar and processed food import and average BMI, we employ a synthetic control method to calculate a counterfactual average BMI in Fiji. We find that sugar and processed food imports are part of the explanation to increasing average BMI in countries; after controlling for globalization and general imports and exports, sugar and processed food imports have a statistically and substantively significant effect in increasing average BMI. In the case of Fiji, the increased prevalence of obesity is associated with trade agreements and increased imports of sugar and processed food. The counterfactual estimates suggest that sugar and processed food imports are associated with a 0.5 increase in average BMI in Fiji.
Globalization and its methodological discontents: Contextualizing globalization through the study of HIV/AIDS

PubMed Central

2011-01-01

There remains considerable discontent between globalization scholars about how to conceptualize its meaning and in regards to epistemological and methodological questions concerning how we can come to understand how these processes ultimately operate, intersect and transform our lives. This article argues that to better understand what globalization is and how it affects issues such as global health, we must take a differentiating approach, which focuses on how the multiple processes of globalization are encountered and informed by different social groups and with how these encounters are experienced within particular contexts. The article examines the heuristic properties of qualitative field research as a means to help better understand how the intersections of globalization are manifested within particular locations. To do so, the article focuses on three recent case studies conducted on globalization and HIV/AIDS and explores how these cases can help us to understand the contextual permutations involved within the processes of globalization. PMID:21861895
An integrative systems biology approach to understanding pulmonary diseases.

PubMed

Auffray, Charles; Adcock, Ian M; Chung, Kian Fan; Djukanovic, Ratko; Pison, Christophe; Sterk, Peter J

2010-06-01

Chronic inflammatory pulmonary diseases such as COPD and asthma are highly prevalent and associated with a major health burden worldwide. Despite a wealth of biologic and clinical information on normal and pathologic airway structure and function, the primary causes and mechanisms of disease remain to a large extent unknown, preventing the development of more efficient diagnosis and treatment. We propose to overcome these limitations through an integrative systems biology research strategy designed to identify the functional and regulatory pathways that play central roles in respiratory pathophysiology, starting with severe asthma. This approach relies on global genome, transcriptome, proteome, and metabolome data sets collected in cross-sectional patient cohorts with high-throughput measurement platforms and integrated with biologic and clinical data to inform predictive multiscale models ranging from the molecular to the organ levels. Working hypotheses formulated on the mechanisms and pathways involved in various disease states are tested through perturbation experiments using model simulation combined with targeted and global technologies in cellular and animal models. The responses observed are compared with those predicted by the initial models, which are refined to account better for the results. Novel perturbation experiments are designed and tested both computationally and experimentally to arbitrate between competing hypotheses. The process is iterated until the derived knowledge allows a better classification and subphenotyping of severe asthma using complex biomarkers, which will facilitate the development of novel diagnostic and therapeutic interventions targeting multiple components of the molecular and cellular pathways involved. This can be tested and validated in prospective clinical trials.
The Global Spine Care Initiative: a consensus process to develop and validate a stratification scheme for surgical care of spinal disorders as a guide for improved resource utilization in low- and middle-income communities.

PubMed

Acaroğlu, Emre; Mmopelwa, Tiro; Yüksel, Selcen; Ayhan, Selim; Nordin, Margareta; Randhawa, Kristi; Haldeman, Scott

2017-10-16

The purpose of this study was to develop a stratification scheme for surgical spinal care to serve as a framework for referrals and distribution of patients with spinal disorders. We used a modified Delphi process. A literature search identified experts for the consensus panel and the panel was expanded by inviting spine surgeons known to be global opinion leaders. After creating a seed document of five hierarchical levels of surgical care, a four-step modified Delphi process (question validation, collection of factors, evaluation of factors, re-evaluation of factors) was performed. Of 78 invited experts, 19 participated in round 1, and of the 19, 14 participated in 2, and 12 in 3 and 4. Consensus was fairly heterogeneous for levels of care 2-4 (moderate resources). Only simple assessment methods based on the clinical skills of the medical personnel were considered feasible and safe in low-resource settings. Diagnosis, staging, and treatment were deemed feasible and safe in a specialized spine center. Accurate diagnostic workup was deemed feasible and safe for lower levels of care complexity (from level 3 upwards) compared to non-invasive procedures (level 4) and the full range of invasive procedures (level 5). This study introduces a five-level stratification scheme for the surgical care of spinal disorders. This stratification may provide input into the Global Spine Care Initiative care pathway that will be applied in medically underserved areas and low- and middle-income countries. These slides can be retrieved under Electronic Supplementary Material.
The development and validation of a new technology, based upon 1.5% arginine, an insoluble calcium compound and fluoride, for everyday use in the prevention and treatment of dental caries.

PubMed

Cummins, D

2013-08-01

This paper briefly discusses caries prevalence, the multi-factorial nature of caries etiology, caries risk and the role and efficacy of fluoride. The paper also highlights research on bacterial metabolism which provided understanding of the mouth's natural defenses against caries and the basis for the development of a new technology for the everyday prevention and treatment of caries. Finally, evidence that the technology complements and enhances the anti-caries efficacy of fluoride toothpaste is summarized. Global data show that dental caries is a prevalent disease, despite the successful introduction of fluoride. Caries experience depends on the balance between consumption of sugars and oral hygiene and the use of fluoride. Three scientific concepts are fundamental to new measures to detect, treat and monitor caries: (1) dental caries is a dynamic process, (2) dental caries is a continuum of stages from reversible, pre-clinical to irreversible, clinically detectable lesions, and (3) the caries process is a balance of pathological and protective factors that can be modulated to manage caries. Fluoride functions as a protective factor by arresting and reversing the caries process, but fluoride does not prevent pathological factors that initiate the process. A novel technology, based upon arginine and an insoluble calcium compound, has been identified which targets dental plaque to prevent initiation of the caries process by reducing pathological factors. As the mechanisms of action of arginine and fluoride are highly complementary, a new dentifrice, which combines arginine with fluoride, has been developed and clinically proven to provide superior caries prevention. Copyright © 2013 Elsevier Ltd. All rights reserved.
Justice in international clinical research.

PubMed

Pratt, Bridget; Loff, Bebe

2011-08-01

Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines. © 2010 Blackwell Publishing Ltd.
Development of an International Clinical Education Extracurricular Experience Through a Collaborative Partnership.

PubMed

Mandich, MaryBeth; Erickson, Mia; Nardella, Beth

2017-01-01

Participating in global health care through international clinical education may enhance the development of cultural competence and professionalism. Many logistical issues need to be resolved in the development of international clinical education experiences that meet program requirements. The purpose of this case report is to describe how a university developed such an experience for students by partnering with Amizade Global Service-Learning (Amizade), an organization that facilitates global learning experiences. Medical, nursing, and pharmacy students were already participating in a 4-week international health-related service learning rotation through Amizade. The preexisting relationship and contractual agreement with the university provided the necessary legal framework. Amizade staff assisted in finding a physical therapist qualified and willing to host a student. The academic coordinator for clinical education at the university and Amizade liaisons determined living arrangements, schedule, clinical settings, and patient population. The selected student had expressed interest and had met all clinical education placement requirements. The academic coordinator for clinical education had ongoing electronic communications with all parties. The student demonstrated predicted attributes of cultural competence and professionalism; through the partnership with Amizade, the student was exposed to several unique interprofessional experiences. The steps used by the university faculty in developing this interprofessional, international clinical education experience through a collaborative partnership may provide guidance for other institutions. © 2017 American Physical Therapy Association

Biosimilars: A consideration of the regulations in the United States and European union.

PubMed

Daller, Justin

2016-04-01

Biosimilars are defined as biological products that are highly similar to a reference product, notwithstanding minor differences in clinically inactive components. Biosimilars show no clinically meaningful differences in safety, purity, and potency of the product in comparison to the reference product. With the ever looming patent expiry of some major high cost biologics, biosimilar production is becoming ever more lucrative to companies. Europe (EU) set the precedent, followed by the United States (US) in early 2012, for the approval process for biosimilars. Therefore, the purpose of this paper is to explore the nature of the regulatory processes in the US and EU and to determine the requirements of each in the approval process of a biosimilar. The current Food and Drug Administration (FDA) and European Medicines Agency's (EMA) guidance documents for biosimilars were reviewed revealing a need for further clarifications, as well as specifically addressing Celltrion's and Sandoz's application for approval for the biosimilars infliximab and filgrastim, respectively. Currently, the FDA and EMA focus on comparability in terms of the clinical, pharmacokinetic (PK)/pharmacodynamic (PD), preclinical, biological activity, and physiochemical characterization results, as well as requiring a robust and consistent manufacturing process. Both the EU and US have prepared guidance documents for biosimilars that will result in biotherapeutics that are as safe and efficacious as the innovator product but the necessity exists to globally harmonize international nonproprietary naming nomenclature and clarify how the concept of pharmacovigilance, extrapolation, and interchangeability will be handled and regulated in the future. Copyright © 2015 Elsevier Inc. All rights reserved.
Evidence-based decision-making within the context of globalization: A “Why–What–How” for leaders and managers of health care organizations

PubMed Central

Lapaige, Véronique

2009-01-01

In the globalized knowledge economy, the challenge of translating knowledge into policy and practice is universal. At the dawn of the 21st century, the clinicians, leaders, and managers of health care organizations are increasingly required to bridge the research-practice gap. A shift from moving evidence to solving problems is due. However, despite a vast literature on the burgeoning field of knowledge translation research, the “evidence-based” issue remains for many health care professionals a day-to-day debate leading to unresolved questions. On one hand, many clinicians still resist to the implementation of evidence-based clinical practice, asking themselves why their current practice should be changed or expanded. On the other hand, many leaders and managers of health care organizations are searching how to keep pace with the demand of actionable knowledge. For example, they are wondering: (a) if managerial and policy innovations are subjected to the same evidentiary standards as clinical innovations, and (b) how they can adapt the scope of evidence-based medicine to the culture, context, and content of health policy and management. This paper focuses on evidence-based health care management within the context of contemporary globalization. In this paper, our heuristic hypothesis is that decision-making process related changes within clinical/managerial/policy environments must be given a socio-historical backdrop. We argue that the relationship between research on the transfer of knowledge and its uptake by clinical, managerial and policy target audiences has undergone a shift, resulting in increasing pressures in health care for intense researcher-practitioner collaboration and the development of “integrative KT platforms” at the crossroads of different fields (the field of knowledge management and the field of knowledge translation). The objectives of this paper are: (a) to provide an answer to the questions that health professionals ask most frequently about “Why” and “How” to bridge the know-do gap, (b) to illustrate by a Canadian example how the PRO-ACTIVE program helps in closing the evidence-based practice gap. PMID:22312206
Asthma in pregnancy: association between the Asthma Control Test and the Global Initiative for Asthma classification and comparisons with spirometry.

PubMed

de Araujo, Georgia Véras; Leite, Débora F B; Rizzo, José A; Sarinho, Emanuel S C

2016-08-01

The aim of this study was to identify a possible association between the assessment of clinical asthma control using the Asthma Control Test (ACT) and the Global Initiative for Asthma (GINA) classification and to perform comparisons with values of spirometry. Through this cross-sectional study, 103 pregnant women with asthma were assessed in the period from October 2010 to October 2013 in the asthma pregnancy clinic at the Clinical Hospital of the Federal University of Pernambuco. Questionnaires concerning the level of asthma control were administered using the Global Initiative for Asthma classification, the Asthma Control Test validated for asthmatic expectant mothers and spirometry; all three methods of assessing asthma control were performed during the same visit between the twenty-first and twenty-seventh weeks of pregnancy. There was a significant association between clinical asthma control assessment using the Asthma Control Test and the Global Initiative for Asthma classification (p<0.001). There were also significant associations between the results of the subjective instruments of asthma (the GINA classification and the ACT) and evidence of lung function by spirometry. This study shows that both the Global Initiative for Asthma classification and the Asthma Control Test can be used for asthmatic expectant mothers to assess the clinical control of asthma, especially at the end of the second trimester, which is assumed to be the period of worsening asthma exacerbations during pregnancy. We highlight the importance of the Asthma Control Test as a subjective instrument with easy application, easy interpretation and good reproducibility that does not require spirometry to assess the level of asthma control and can be used in the primary care of asthmatic expectant mothers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Violence Against Women

PubMed Central

Fulu, Emma; Miedema, Stephanie

2015-01-01

Globalization theories have proliferated over the past two decades. However, global developments have yet to be systematically incorporated into theories around violence against women. This article proposes to add a global level to the existing ecological model framework, popularized by Lori Heise in 1998, to explore the relationships between global processes and experiences of violence against women. Data from the Maldives and Cambodia are used to assess how globalized ideologies, economic development and integration, religious fundamentalisms, and global cultural exchange, as components of a larger globalization process, have affected men and women’s experiences and perceptions of violence against women. PMID:26215287
Global Health Education in Pulmonary and Critical Care Medicine Fellowships.

PubMed

Siddharthan, Trishul; North, Crystal M; Attia, Engi F; Christiani, David C; Checkley, William; West, T Eoin

2016-06-01

A growing number of pulmonary and critical care medicine fellowship programs in the United States offer global health training opportunities. Formal, integrated global health programs within pulmonary and critical care fellowships are relatively new but are built on principles and ideals of global health that focus on the mutually beneficial exchange of knowledge and social justice. Although core competencies consistent with these overarching themes in global health education have not been formalized for pulmonary and critical care trainees, relevant competency areas include clinical knowledge, international research training, cultural competency, and clinical and research capacity building. Existing global health education in U.S. pulmonary and critical care medicine training programs can generally be classified as one of three different models: integrated global health tracks, global health electives, and additional research years. Successful global health education programs foster partnerships and collaborations with international sites that emphasize bidirectional exchange. This bidirectional exchange includes ongoing, equitable commitments to mutual opportunities for training and professional development, including a focus on the particular knowledge and skill sets critical for addressing the unique priorities of individual countries. However, barriers related to the availability of mentorship, funding, and dedicated time exist to expanding global health education in pulmonary and critical care medicine. The implementation of global health training within pulmonary and critical care medicine programs requires continued optimization, but this training is essential to prepare the next generation of physicians to address the global aspects of respiratory disease and critical illness.
Ebola Check: Delivering molecular diagnostics at the point of need.

PubMed

Moschos, Sterghios A

2015-01-01

The 2013-5 global outbreak of Ebolavirus disease brought to sharp focus the need for diagnostic capacity to be equitably available on a global scale: from the most under-developed areas of resource-limited countries in West Africa to high volume international travel hubs in Europe and the USA. Quick detection of the causal agent of disease is pivotal to containment, contact tracing and clinical action to protect healthcare workers, communities and patients. Nucleic acid testing (NAT) by real time reverse transcription quantitative polymerase chain reaction (RT-PCR) has emerged as the preferred method for reliable patient status confirmation. Presently, this is served through advanced clinical molecular laboratory testing in a <8hr manual process that requires 3.5ml venous blood samples. To meet the demand in West Africa, this has necessitated large-scale mobile laboratory and volunteer biomedical scientist deployment: a solution that has proven eventually adequate, albeit temporary against future re-emergence of this and other haemorrhagic fever disease agents prevalent in the region. The EbolaCheck consortium was formed in August 2014 to address the need for delivering NAT at the point of care. We have developed a novel platform technology that can QUantitatively, RAPidly IDentify (QuRapID) known RNA or DNA targets in viruses, bacteria, or eukaryotic cells directly in crude biofluids, including whole blood, in under 40min using a 5 microliter sample. The portable, battery-operated system lacks microfluidics, pumps or other sensitive/high cost parts making it suitable for the environmental and economic challenges of resource-limited countries. The simple, safe, 5-step sample-to-answer process requires minimal training and informs frontline healthcare workers of diagnostic status, whilst reporting remotely epidemiologically relevant results. Data on biosafety level 2 surrogate Ebolavirus templates presented in encapsulated or enveloped viruses indicate performance comparable to clinical laboratory testing and utility beyond filoviruses. Emerging performance data on live Ebolavirus, non-human primate disease model and patient samples, as well as future development plans will be discussed.
Common Elements in Rare Kidney Diseases: Conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference.

PubMed

Aymé, Ségolène; Bockenhauer, Detlef; Day, Simon; Devuyst, Olivier; Guay-Woodford, Lisa M; Ingelfinger, Julie R; Klein, Jon B; Knoers, Nine V A M; Perrone, Ronald D; Roberts, Julia; Schaefer, Franz; Torres, Vicente E; Cheung, Michael; Wheeler, David C; Winkelmayer, Wolfgang C

2017-10-01

Rare kidney diseases encompass at least 150 different conditions, most of which are inherited. Although individual rare kidney diseases raise specific issues, as a group these rare diseases can have overlapping challenges in diagnosis and treatment. These challenges include small numbers of affected patients, unidentified causes of disease, lack of biomarkers for monitoring disease progression, and need for complex care. To address common clinical and patient issues among rare kidney diseases, the KDIGO Controversies Conference entitled, Common Elements in Rare Kidney Diseases, brought together a panel of multidisciplinary clinical providers and patient advocates to address five central issues for rare kidney diseases. These issues encompassed diagnostic challenges, management of kidney functional decline and progression of chronic kidney disease, challenges in clinical study design, translation of advances in research to clinical care, and provision of practical and integrated patient support. Thus, by a process of consensus, guidance for addressing these challenges was developed and is presented here. Copyright © 2017 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.
Personalized Medicine for ARDS: The 2035 Research Agenda

PubMed Central

Beitler, Jeremy R.; Goligher, Ewan C.; Schmidt, Matthieu; Spieth, Peter M.; Zanella, Alberto; Martin-Loeches, Ignacio; Calfee, Carolyn S.; Cavalcanti, Alexandre B.

2016-01-01

Survival from ARDS has increased substantially in the last twenty years as a result of key advances in lung-protective ventilation and resuscitation. Similarly, clinical practice improvements have contributed to an impressive decline in nosocomial ARDS incidence. Personalizing mechanical ventilation for further lung protection is a top research priority for the years ahead. However, the ARDS research agenda must be broader in scope. The clinical syndrome of ARDS includes a heterogeneous assemblage of pathophysiological processes leading to lung injury. Further understanding of these varied, complex biological underpinnings of ARDS pathogenesis is needed to inform therapeutic discovery and tailor management strategy to the individual patient. While some therapies may be applicable broadly to all ARDS patients, others may benefit only certain biologically distinct subsets. The twenty-year ARDSne(x)t research agenda calls for bringing personalized medicine to ARDS, asking simultaneously both whether a treatment affords clinically meaningful benefit and for whom. This expanded scope necessitates acquisition of highly granular biological, physiological, and clinical data as the new standard across studies. Tremendous investment in research infrastructure and global collaboration will be vital to fulfilling this agenda. PMID:27040103
American Society of Clinical Oncology policy statement: oversight of clinical research.

PubMed

2003-06-15

Well-publicized lapses in the review or implementation of clinical research studies have raised public questions about the integrity of the clinical research process. Public trust in the integrity of research is critical not only for funding and participation in clinical trials but also for confidence in the treatments that result from the trials. The questions raised by these unfortunate cases pose an important opportunity to reassess the clinical trials oversight system to ensure the integrity of clinical research and the safety of those who enroll in clinical trials. Since its inception, the American Society of Clinical Oncology (ASCO) has worked for the advancement of cancer treatments through clinical research and to help patients gain prompt access to scientifically excellent and ethically unimpeachable clinical trials. As an extension of its mission, ASCO is affirming with this policy statement the critical importance of a robust review and oversight system to ensure that clinical trials participants give fully informed consent and that their safety is a top priority. Ensuring the integrity of research cannot be stressed enough because of its seminal connection to the advancement of clinical cancer treatment. The overall goal of this policy is to enhance public trust in the cancer clinical trials process. To achieve this, the following elements are essential: 1. Ensure safety precautions for clinical trial participants and their fully informed consent. 2. Ensure the validity and integrity of scientific research. 3. Enhance the educational training of clinical scientists and research staff to ensure the highest standards of research conduct. 4. Promote accountability and responsibility among all those involved in clinical research (not just those serving on institutional review boards [IRBs], but also institutional officials, researchers, sponsors, and participants) and ensure support for an effective oversight process. 5. Enhance the professional and public understanding of clinical research oversight. 6. Enhance the efficiency and cost-effectiveness of the clinical research oversight system. This policy statement makes recommendations in several areas that serve as principles to support an improved system of oversight for clinical research. ASCO will work with all parties involved in the clinical research system to develop the steps necessary to implement these recommendations. Centralized Trial Review: A large percentage of oncology clinical trials are coordinated through the National Cancer Institute's (NCI) system of cooperative groups, which already incorporates centralized scientific review. As such, there is a tremendous opportunity to employ a centralized mechanism to provide ethical review by highly trained IRB members, allowing local IRBs to take advantage of the financial and time efficiencies that central review provides. Centralized review boards (CRBs) would also contribute consistency and efficiency to the process. Once successfully completed, the review would represent an approval to open the protocol at all of the institutions that have subscribed to the centralized review system. Local IRBs would be able to devote time usually spent on initial review to ongoing monitoring of the trial taking place at their institution. Considering the enormous size and complexity of the clinical research enterprise, ASCO envisions multiple CRBs, which could be distributed as regional review boards. Central review will use a single protocol and consent form, and monitor and evaluate adverse events (AEs) on a global basis, eliminating many of the time-consuming steps for the local IRB. Global monitoring and assessment of AEs has real potential to enhance trial participants' safety by giving local institutions more information on the overall trial and enabling them to devote more time to ongoing review of the trial onsite. Use of a CRB also has real potential to reduce the costs of clinical trial oversight by allowing local IRBs to eliminate the costs of initial review. These efficiencies will likely lead to institutions redirecting funds toward monitoring ongoing trials. Although a CRB has potential to improve the efficiency of the process, a CRB could also have tremendous ability to delay valuable trials. Checks and balances must be included in the newly devised system to ensure timely review and appeals of CRB actions. ASCO proposes the advent of a new pilot program for centralizing review of clinical trials. It requires clear engagement of all stakeholders in planning the experiment, clear articulation of the goals, and assurance of federal regulatory protection for institutions choosing to participate. If successful, this CRB pilot project could be expanded to include multi-institutional industry-sponsored research. Education and Training:Education and training are critical to the ultimate success of an improved oversight system. All members of the research team should receive comprehensive education on conducting scientifically and ethically valid clinical research. The curriculum should also include information on the prevailing local and federal regulations that pertain to the clinical trials process. IRB members should also receive ongoing education and training in the review of clinical research protocols. IRB training should pay particular attention to nonscientific members to give them the tools necessary to speak on behalf of research participants. ASCO should develop a curriculum that focuses on the proper conduct of human research and emphasize ethically sound clinical research in the context of its Annual Meeting. Informed Consent: Investigators and review boards have specific roles to play in ensuring the education of trial participants through the informed consent process, both when they are considering trial enrollment and as they participate in the trial. Review boards and investigators should focus primarily on the informed consent process, rather than the informed consent documents. Federal Oversight: The federal government has an important role to play in the oversight of clinical research. This role should be expanded to cover all research, not just that which is funded by the federal government or conducted with the oversight of the Food and Drug Administration (FDA). The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the FDA should provide clear regulatory support and guidance for local institutions that choose to employ a CRB. In the case of the pilot CRB discussed in this policy statement, it should serve as the preferred option for the cancer cooperative group clinical trials. Ideally, the federal government should unify and streamline its regulations for the oversight of clinical research. Resources Supporting Clinical Research Infrastructure:An effective oversight process demands the highest quality scientific and ethical review and onsite monitoring of the safety of trial participants. This can only be accomplished by the involvement of an experienced IRB that receives funding, resources, and institutional support enabling it to fulfill its mandate. Critical to the integrity of research is the absence of bias in the process. ASCO strongly recommends the adoption of standards for the identification, management, and, where appropriate, elimination of conflicts of interests, whether they are actual, potential, or apparent.
Developmental origins of health and disease--global public health implications.

PubMed

Hanson, M A; Gluckman, P D

2015-01-01

The rapidly rising prevalence of non-communicable diseases (NCDs) represents a major challenge to public health and clinical medicine globally. NCDs are increasing rapidly in high-income countries, but even more rapidly in some low-middle-income countries with insufficient resources to meet the challenge. Whilst not identified in the Millennium Development Goals, there is much attention paid to NCDs in the discussions at many levels on the Sustainable Development Goals, as they underpin economic, social and environmental development in the post-2015 era. In this article, we discuss how a life-course approach to health, commencing of necessity in early development, can provide new opportunities for addressing this challenge. The approach can leverage human health capital throughout life and across generations. New insights into mechanisms, especially those processes by which the developmental environment affects epigenetic processes in the developing offspring, offer the prospect of identifying biomarkers of future risks. New interventions to promote health literacy, lifestyle and physical fitness in adolescents, young adults and their children hold great promise. In this respect, health-care professionals concerned with preconceptional, pregnancy and newborn care will have a vital role to play. Copyright © 2014 Elsevier Ltd. All rights reserved.
The Integration of Object Levels and Their Content: A Theory of Global/Local Processing and Related Hemispheric Differences

ERIC Educational Resources Information Center

Hubner, Ronald; Volberg, Gregor

2005-01-01

This article presents and tests the authors' integration hypothesis of global/local processing, which proposes that at early stages of processing, the identities of global and local units of a hierarchical stimulus are represented separately from information about their respective levels and that, therefore, identity and level information have to…
Global Consensus Recommendations on Prevention and Management of Nutritional Rickets

PubMed Central

Munns, Craig F.; Shaw, Nick; Kiely, Mairead; Specker, Bonny L.; Thacher, Tom D.; Ozono, Keiichi; Michigami, Toshimi; Tiosano, Dov; Mughal, M. Zulf; Mäkitie, Outi; Ramos-Abad, Lorna; Ward, Leanne; DiMeglio, Linda A.; Atapattu, Navoda; Cassinelli, Hamilton; Braegger, Christian; Pettifor, John M.; Seth, Anju; Idris, Hafsatu Wasagu; Bhatia, Vijayalakshmi; Fu, Junfen; Goldberg, Gail; Sävendahl, Lars; Khadgawat, Rajesh; Pludowski, Pawel; Maddock, Jane; Hyppönen, Elina; Oduwole, Abiola; Frew, Emma; Aguiar, Magda; Tulchinsky, Ted; Butler, Gary

2016-01-01

Background: Vitamin D and calcium deficiencies are common worldwide, causing nutritional rickets and osteomalacia, which have a major impact on health, growth, and development of infants, children, and adolescents; the consequences can be lethal or can last into adulthood. The goals of this evidence-based consensus document are to provide health care professionals with guidance for prevention, diagnosis, and management of nutritional rickets and to provide policy makers with a framework to work toward its eradication. Evidence: A systematic literature search examining the definition, diagnosis, treatment, and prevention of nutritional rickets in children was conducted. Evidence-based recommendations were developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system that describe the strength of the recommendation and the quality of supporting evidence. Process: Thirty-three nominated experts in pediatric endocrinology, pediatrics, nutrition, epidemiology, public health, and health economics evaluated the evidence on specific questions within five working groups. The consensus group, representing 11 international scientific organizations, participated in a multiday conference in May 2014 to reach a global evidence-based consensus. Results: This consensus document defines nutritional rickets and its diagnostic criteria and describes the clinical management of rickets and osteomalacia. Risk factors, particularly in mothers and infants, are ranked, and specific prevention recommendations including food fortification and supplementation are offered for both the clinical and public health contexts. Conclusion: Rickets, osteomalacia, and vitamin D and calcium deficiencies are preventable global public health problems in infants, children, and adolescents. Implementation of international rickets prevention programs, including supplementation and food fortification, is urgently required. PMID:26745253
Population-level genomics identifies the emergence and global spread of a human transmissible multidrug-resistant nontuberculous mycobacterium

PubMed Central

Rodriguez-Rincon, Daniela; Everall, Isobel; Brown, Karen P; Moreno, Pablo; Verma, Deepshikha; Hill, Emily; Drijkoningen, Judith; Gilligan, Peter; Esther, Charles R; Noone, Peadar G; Giddings, Olivia; Bell, Scott C.; Thomson, Rachel; Wainwright, Claire E.; Coulter, Chris; Pandey, Sushil; Wood, Michelle E; Stockwell, Rebecca E; Ramsay, Kay A; Sherrard, Laura J; Kidd, Timothy J; Jabbour, Nassib; Johnson, Graham R; Knibbs, Luke D; Morawska, Lidia; Sly, Peter D; Jones, Andrew; Bilton, Diana; Laurenson, Ian; Ruddy, Michael; Bourke, Stephen; Bowler, Ian CJW; Chapman, Stephen J; Clayton, Andrew; Cullen, Mairi; Daniels, Thomas; Dempsey, Owen; Denton, Miles; Desai, Maya; Drew, Richard J; Edenborough, Frank; Evans, Jason; Folb, Jonathan; Humphrey, Helen; Isalska, Barbara; Jensen-Fangel, Søren; Jönsson, Bodil; Jones, Andrew M.; Katzenstein, Terese L; Lillebaek, Troels; MacGregor, Gordon; Mayell, Sarah; Millar, Michael; Modha, Deborah; Nash, Edward F; O’Brien, Christopher; O’Brien, Deirdre; Ohri, Chandra; Pao, Caroline S; Peckham, Daniel; Perrin, Felicity; Perry, Audrey; Pressler, Tania; Prtak, Laura; Qvist, Tavs; Robb, Ali; Rodgers, Helen; Schaffer, Kirsten; Shafi, Nadia; van Ingen, Jakko; Walshaw, Martin; Watson, Danie; West, Noreen; Whitehouse, Joanna; Haworth, Charles S; Harris, Simon R; Ordway, Diane; Parkhill, Julian; Floto, R. Andres

2016-01-01

Lung infections with Mycobacterium abscessus, a species of multidrug resistant nontuberculous mycobacteria, are emerging as an important global threat to individuals with cystic fibrosis (CF) where they accelerate inflammatory lung damage leading to increased morbidity and mortality. Previously, M. abscessus was thought to be independently acquired by susceptible individuals from the environment. However, using whole genome analysis of a global collection of clinical isolates, we show that the majority of M. abscessus infections are acquired through transmission, potentially via fomites and aerosols, of recently emerged dominant circulating clones that have spread globally. We demonstrate that these clones are associated with worse clinical outcomes, show increased virulence in cell-based and mouse infection models, and thus represent an urgent international infection challenge. PMID:27846606
A de-identifier for medical discharge summaries.

PubMed

Uzuner, Ozlem; Sibanda, Tawanda C; Luo, Yuan; Szolovits, Peter

2008-01-01

Clinical records contain significant medical information that can be useful to researchers in various disciplines. However, these records also contain personal health information (PHI) whose presence limits the use of the records outside of hospitals. The goal of de-identification is to remove all PHI from clinical records. This is a challenging task because many records contain foreign and misspelled PHI; they also contain PHI that are ambiguous with non-PHI. These complications are compounded by the linguistic characteristics of clinical records. For example, medical discharge summaries, which are studied in this paper, are characterized by fragmented, incomplete utterances and domain-specific language; they cannot be fully processed by tools designed for lay language. In this paper, we show that we can de-identify medical discharge summaries using a de-identifier, Stat De-id, based on support vector machines and local context (F-measure=97% on PHI). Our representation of local context aids de-identification even when PHI include out-of-vocabulary words and even when PHI are ambiguous with non-PHI within the same corpus. Comparison of Stat De-id with a rule-based approach shows that local context contributes more to de-identification than dictionaries combined with hand-tailored heuristics (F-measure=85%). Comparison with two well-known named entity recognition (NER) systems, SNoW (F-measure=94%) and IdentiFinder (F-measure=36%), on five representative corpora show that when the language of documents is fragmented, a system with a relatively thorough representation of local context can be a more effective de-identifier than systems that combine (relatively simpler) local context with global context. Comparison with a Conditional Random Field De-identifier (CRFD), which utilizes global context in addition to the local context of Stat De-id, confirms this finding (F-measure=88%) and establishes that strengthening the representation of local context may be more beneficial for de-identification than complementing local with global context.
A De-identifier for Medical Discharge Summaries1

PubMed Central

Uzuner, Özlem; Sibanda, Tawanda C.; Luo, Yuan; Szolovits, Peter

2008-01-01

Objective Clinical records contain significant medical information that can be useful to researchers in various disciplines. However, these records also contain personal health information (PHI) whose presence limits the use of the records outside of hospitals. The goal of de-identification is to remove all PHI from clinical records. This is a challenging task because many records contain foreign and misspelled PHI; they also contain PHI that are ambiguous with non-PHI. These complications are compounded by the linguistic characteristics of clinical records. For example, medical discharge summaries, which are studied in this paper, are characterized by fragmented, incomplete utterances and domain-specific language; they cannot be fully processed by tools designed for lay language. Methods and Results In this paper, we show that we can de-identify medical discharge summaries using a de-identifier, Stat De-id, based on support vector machines and local context (F-measure = 97% on PHI). Our representation of local context aids de-identification even when PHI include out-of-vocabulary words and even when PHI are ambiguous with non-PHI within the same corpus. Comparison of Stat De-id with a rule-based approach shows that local context contributes more to de-identification than dictionaries combined with hand-tailored heuristics (F-measure = 85%). Comparison with two well-known named entity recognition (NER) systems, SNoW (F-measure = 94%) and IdentiFinder (F-measure = 36%), on five representative corpora show that when the language of documents is fragmented, a system with a relatively thorough representation of local context can be a more effective de-identifier than systems that combine (relatively simpler) local context with global context. Comparison with a Conditional Random Field De-identifier (CRFD), which utilizes global context in addition to the local context of Stat De-id, confirms this finding (F-measure = 88%) and establishes that strengthening the representation of local context may be more beneficial for de-identification than complementing local with global context. PMID:18053696
Global Citizenship Education and Its Implications for Curriculum Goals at the Age of Globalization

ERIC Educational Resources Information Center

Zahabioun, Shahla; Yousefy, Alireza; Yarmohammadian, Mohammad H.; Keshtiaray, Narges

2013-01-01

As the inevitable process of the 21st century, globalization has affected and altered all aspects of human life including education. Therefore, one of the main tasks of any education system is to identify the features and impacts of such process. Thus, the present study was conducted aiming to discuss and examine global citizenship education and…
[Attention deficits and response to drug therapy in patients with treatment-resistant schizophrenia: results through confirmatory factor analysis].

PubMed

Sánchez, Pedro; Ojeda, Natalia; Elizagárate, Edorta; Peña, Javier; Ballesteros, Javier; Yoller, Ana B; Gutiérrez, Miguel; Casais, Leonardo; Ezcurra, Jesús

2010-04-01

There are no experimental data that demonstrate whether patients with neuroleptic-resistant schizophrenia differ or not in their pattern of neuropsychological functioning from patients with adequate drug response. Fifty-two patients with drug-resistant psychosis (DRP) and 42 patients with schizophrenia not resistant to treatment (NDRP) were recruited following the criteria of Kane et al (1988). A sample of 45 healthy controls matched by age, sex and educational level was also recruited. The clinical evaluations used were the Positive and Negative Symptom Scale (PANSS), functional disability (WHO-DAS) and the Clinical Global Impression (CGI) scale. Through the use of confirmatory factor analysis, we obtained a latent cognitive structure of six cognitive factors: attention, processing speed, verbal memory, working memory, verbal fluency and executive functions. As expected, the control group performed better than the two patient groups (both DRP and NDRP) in all neuropsychological domains. Additionally, the DRP group scored significantly worse in attention than the NDRP group even though no differences between these two groups were found in age of disease onset, number of hospitalizations or length of hospitalization. From a clinical point of view, the DRP group showed greater severity of positive symptoms (p<0.01) and higher global deterioration (p<0.01), which did not translate into greater functional disability. The results obtained do not allow us to conclude that there is a specific neuropsychological profile in neuroleptic-resistant patients. The only differential parameter was performance in the attentional domain. Our findings better fit the hypothesis of a «clinical continuum» and differ from the categoric classification of this mental disorder. Copyright © 2009 SEP y SEPB. Published by Elsevier Espana. All rights reserved.
The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials.

PubMed

Stanmore, Emma; Stubbs, Brendon; Vancampfort, Davy; de Bruin, Eling D; Firth, Joseph

2017-07-01

Physically-active video games ('exergames') have recently gained popularity for leisure and entertainment purposes. Using exergames to combine physical activity and cognitively-demanding tasks may offer a novel strategy to improve cognitive functioning. Therefore, this systematic review and meta-analysis was performed to establish effects of exergames on overall cognition and specific cognitive domains in clinical and non-clinical populations. We identified 17 eligible RCTs with cognitive outcome data for 926 participants. Random-effects meta-analyses found exergames significantly improved global cognition (g=0.436, 95% CI=0.18-0.69, p=0.001). Significant effects still existed when excluding waitlist-only controlled studies, and when comparing to physical activity interventions. Furthermore, benefits of exergames where observed for both healthy older adults and clinical populations with conditions associated with neurocognitive impairments (all p<0.05). Domain-specific analyses found exergames improved executive functions, attentional processing and visuospatial skills. The findings present the first meta-analytic evidence for effects of exergames on cognition. Future research must establish which patient/treatment factors influence efficacy of exergames, and explore neurobiological mechanisms of action. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.
[Clinical course of multiple sclerosis in patients treated with cytostatic drugs for cancer].

PubMed

Santos-García, D; Prieto, J M; Lema, M

The risk of side effects secondary to global and non-specific immune suppression has limited the systematic application of immunosuppressive therapy in multiple sclerosis (MS). However, when a patient with MS develops a cancer, cytostatic drugs as treatment for the neoplastic process may induce improvement not only of the cancer but also of MS. We present a series of four women with clinically defined MS and subjected to cytostatic therapy (cisplatin, 5-fluorouracil, leukovorin, adriamycin, tamoxifen and anastrozole) after the development of cancer: two presented breast cancer, one colon cancer, and the fourth parotid gland malignancy. Their clinical and neuroimaging course is described, following chemotherapy for the malignant disease. None of the patients have suffered further MS outbreaks. The four women have improved and remain clinically stable after neoplastic treatment. Magnetic resonance imaging showed persistence of the same lesion burden in three patients, and reduction in the other. At the present one patient receives weekly intramuscular interferon-beta 1a, whereas the other did not received any treatment. Probably there are no specific cytostatics for MS. Immunosuppressive therapy could be a therapeutic option among patients with an aggressive clinical course.
Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials.

PubMed

Van Heertum, Ronald L; Scarimbolo, Robert; Ford, Robert; Berdougo, Eli; O'Neal, Michael

2015-01-01

In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes.

Challenges in reducing dengue burden; diagnostics, control measures and vaccines.

PubMed

Lam, Sai Kit

2013-09-01

Dengue is a major public health concern worldwide, with the number of infections increasing globally. The illness imposes the greatest economic and human burden on developing countries that have limited resources to deal with the scale of the problem. No cure for dengue exists; treatment is limited to rehydration therapy, and with vector control strategies proving to be relatively ineffective, a vaccine is an urgent priority. Despite the numerous challenges encountered in the development of a dengue vaccine, several vaccine candidates have shown promise in clinical development and it is believed that a vaccination program would be at least as cost-effective as current vector control programs. The lead candidate vaccine is a tetravalent, live attenuated, recombinant vaccine, which is currently in Phase III clinical trials. Vaccine introduction is a complex process that requires consideration and is discussed here. This review discusses the epidemiology, burden and pathogenesis of dengue, as well as the vaccine candidates currently in clinical development.
Exploring global recognition of quality midwifery education: Vision or fiction?

PubMed

Luyben, Ans; Barger, Mary; Avery, Melissa; Bharj, Kuldip Kaur; O'Connell, Rhona; Fleming, Valerie; Thompson, Joyce; Sherratt, Della

2017-06-01

Midwifery education is the foundation for preparing competent midwives to provide a high standard of safe, evidence-based care for women and their newborns. Global competencies and standards for midwifery education have been defined as benchmarks for establishing quality midwifery education and practice worldwide. However, wide variations in type and nature of midwifery education programs exist. To explore and discuss the opportunities and challenges of a global quality assurance process as a strategy to promote quality midwifery education. Accreditation and recognition as two examples of quality assurance processes in education are discussed. A global recognition process, with its opportunities and challenges, is explored from the perspective of four illustrative case studies from Ireland, Kosovo, Latin America and Bangladesh. The discussion highlights that the establishment of a global recognition process may assist in promoting quality of midwifery education programs world-wide, but cannot take the place of formal national accreditation. In addition, a recognition process will not be feasible for many institutions without additional resources, such as financial support or competent evaluators. In order to achieve quality midwifery education through a global recognition process the authors present 5 Essential Challenges for Quality Midwifery Education. Quality midwifery education is vital for establishing a competent workforce, and improving maternal and newborn health. Defining a global recognition process could be instrumental in moving toward this goal, but dealing with the identified challenges will be essential. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.
The Not-So-Global Blood Oxygen Level-Dependent Signal.

PubMed

Billings, Jacob; Keilholz, Shella

2018-04-01

Global signal regression is a controversial processing step for resting-state functional magnetic resonance imaging, partly because the source of the global blood oxygen level-dependent (BOLD) signal remains unclear. On the one hand, nuisance factors such as motion can readily introduce coherent BOLD changes across the whole brain. On the other hand, the global signal has been linked to neural activity and vigilance levels, suggesting that it contains important neurophysiological information and should not be discarded. Any widespread pattern of coordinated activity is likely to contribute appreciably to the global signal. Such patterns may include large-scale quasiperiodic spatiotemporal patterns, known also to be tied to performance on vigilance tasks. This uncertainty surrounding the separability of the global BOLD signal from concurrent neurological processes motivated an examination of the global BOLD signal's spatial distribution. The results clarify that although the global signal collects information from all tissue classes, a diverse subset of the BOLD signal's independent components contribute the most to the global signal. Further, the timing of each network's contribution to the global signal is not consistent across volunteers, confirming the independence of a constituent process that comprises the global signal.
Furthering the Validity of a Tool to Assess Simulated Pregnancy Options Counseling Skills.

PubMed

Lupi, Carla; Ward-Peterson, Melissa; Coxe, Stefany; Minor, Suzanne; Eliacin, Irmanie; Obeso, Vivian

2016-10-01

To further the validity of a tool to assess nondirective pregnancy options counseling skills. Using a cross-sectional design, we explored four sources of construct validity evidence for an objective structured clinical examination for training and assessment of nondirective pregnancy options counseling: content, response process, internal structure, and relations to other variables. Content of the previously developed tool was enhanced through input from five family medicine educators. The objective structured clinical examination was implemented in a family medicine clerkship with third-year medical students from 2014 to 2015 using trained raters. Response process was addressed after a pilot round. Three new raters evaluated videotapes of 46 performances. Cronbach's alpha, intraclass correlation coefficients, and Spearman's rho were estimated with 95% confidence intervals. The content validity was affirmed. Cronbach's alpha was 0.71. According to Landis and Koch's criteria, all but two items unique to the clinical situation of pregnancy options counseling generated substantial to perfect agreement (0.62-1.00). Relations to other variables within the checklist were strong, ranging from 0.66 to 0.87. This tool for assessing pregnancy options counseling skills has excellent content and strong internal structure. Further work to improve the Global Rating Scale may be necessary for summative use.
Using an evidence-based approach to measure outcomes in clinical practice.

PubMed

MacDermid, Joy C; Grewal, Ruby; MacIntyre, Norma J

2009-02-01

Evaluation of the outcome of evidence-based practice decisions in individual patients or patient groups is step five in the evidence-based practice approach. Outcome measures are any measures that reflect patient status. Status or outcome measures can be used to detect change over time (eg, treatment effects), to discriminate among clinical groups, or to predict future outcomes (eg, return to work). A variety of reliable and valid physical impairment and disability measures are available to assess treatment outcomes in hand surgery and therapy. Evidence from research studies that includes normative data, standard error of measurement, or comparative scores for important clinical subgroups can be used to set treatment goals, monitor recovery, and compare individual patient outcomes to those reported in the literature. Clinicians tend to rely on impairment measures, such as radiographic measures, grip strength, and range of motion, although self-report measures are known to be equally reliable and more related to global effects, such as return-to-work. The process of selecting and implementing outcome measures is crucial. This process works best when team members are involved and willing to trial new measures. In this way, the team can develop customized outcome assessment procedures that meet their needs for assessing individual patients and providing data for program evaluation.
Quality Assurance and Improvement in Head and Neck Cancer Surgery: From Clinical Trials to National Healthcare Initiatives.

PubMed

Simon, Christian; Caballero, Carmela

2018-05-24

It is without question in the best interest of our patients, if we can identify ways to improve the quality of care we deliver to them. Great progress has been made within the last 25 years in terms of development and implementation of quality-assurance (QA) platforms and quality improvement programs for surgery in general, and within this context for head and neck surgery. As of now, we have successfully identified process indicators that impact outcome of our patients and the quality of care we deliver as surgeons. We have developed risk calculators to determine the risk for complications of individual surgical patients. We have created perioperative guidelines for complex head and neck procedures. We have in Europe and North America created audit registries that can gather and analyze data from institutions across the world to better understand which processes need change to obtain good outcomes and improve quality of care. QA platforms can be tested within the clearly defined environment of prospective clinical trials. If positive, such programs could be rolled out within national healthcare systems, if feasible. Testing quality programs in clinical trials could be a versatile tool to help head neck cancer patients benefit directly from such initiatives on a global level.
Clinical and pathological implications of miRNA in bladder cancer

PubMed Central

Braicu, Cornelia; Cojocneanu-Petric, Roxana; Chira, Sergiu; Truta, Anamaria; Floares, Alexandru; Petrut, Bogdan; Achimas-Cadariu, Patriciu; Berindan-Neagoe, Ioana

2015-01-01

MicroRNAs (miRNAs) are small, noncoding RNA species with a length of 20–22 nucleotides that are recognized as essential regulators of relevant molecular mechanisms, including carcinogenesis. Current investigations show that miRNAs are detectable not only in different tissue types but also in a wide range of biological fluids, either free or trapped in circulating microvesicles. miRNAs were proven to be involved in cell communication, both in pathological and physiological processes. Evaluation of the global expression patterns of miRNAs provides key opportunities with important practical applications, taking into account that they modulate essential biological processes such as epithelial to mesenchymal transition, which is a mechanism relevant in bladder cancer. miRNAs collected from biological specimens can furnish valuable evidence with regard to bladder cancer oncogenesis, as they also have been linked to clinical outcomes in urothelial carcinoma. Therefore, a single miRNA or a signature of multiple miRNAs may improve risk stratification of patients and may supplement the histological diagnosis of urological tumors, particularly for bladder cancer. PMID:25653521
The Future of HIV Vaccine Research and the Role of the Global HIV Vaccine Enterprise

PubMed Central

Voronin, Yegor; Manrique, Amapola; Bernstein, Alan

2010-01-01

Purpose of review This review covers the role of the Global HIV Vaccine Enterprise (the Enterprise), an alliance of independent organizations committed to development of a safe and effective HIV vaccine. It discussesthe history, impact on the field and future directions and initiatives of the alliance, in the context of recent progress in HIV vaccine research and development. Recent Findings Significant progress has been made in the field since the release of the 2005 Scientific Strategic Plan (The Plan) of the Enterprise. Over the last year, the Enterprise embarked on an impact assessment of the 2005 Planand the development of the 2010 Plan. Enterprise Working Groups identified key priorities in the field, several of which are discussed in this review, including: changing the nature, purpose and process of clinical trials; increasing and facilitating data sharing; and optimizing existing and attracting new resources. Summary This isan important moment in HIV vaccine research. New clinical trial and laboratory results have created new opportunities to advance the search for an HIV vaccineand reinvigorated the field. The Enterprise will publish its 2010 Scientific Strategic Planthis year, providinga framework for setting new priorities and directions, and encouraging new and existing partners to embark on a shared scientific agenda. PMID:20978383
A surrogate-based metaheuristic global search method for beam angle selection in radiation treatment planning.

PubMed

Zhang, H H; Gao, S; Chen, W; Shi, L; D'Souza, W D; Meyer, R R

2013-03-21

An important element of radiation treatment planning for cancer therapy is the selection of beam angles (out of all possible coplanar and non-coplanar angles in relation to the patient) in order to maximize the delivery of radiation to the tumor site and minimize radiation damage to nearby organs-at-risk. This category of combinatorial optimization problem is particularly difficult because direct evaluation of the quality of treatment corresponding to any proposed selection of beams requires the solution of a large-scale dose optimization problem involving many thousands of variables that represent doses delivered to volume elements (voxels) in the patient. However, if the quality of angle sets can be accurately estimated without expensive computation, a large number of angle sets can be considered, increasing the likelihood of identifying a very high quality set. Using a computationally efficient surrogate beam set evaluation procedure based on single-beam data extracted from plans employing equallyspaced beams (eplans), we have developed a global search metaheuristic process based on the nested partitions framework for this combinatorial optimization problem. The surrogate scoring mechanism allows us to assess thousands of beam set samples within a clinically acceptable time frame. Tests on difficult clinical cases demonstrate that the beam sets obtained via our method are of superior quality.
A surrogate-based metaheuristic global search method for beam angle selection in radiation treatment planning

PubMed Central

Zhang, H H; Gao, S; Chen, W; Shi, L; D’Souza, W D; Meyer, R R

2013-01-01

An important element of radiation treatment planning for cancer therapy is the selection of beam angles (out of all possible coplanar and non-coplanar angles in relation to the patient) in order to maximize the delivery of radiation to the tumor site and minimize radiation damage to nearby organs-at-risk. This category of combinatorial optimization problem is particularly difficult because direct evaluation of the quality of treatment corresponding to any proposed selection of beams requires the solution of a large-scale dose optimization problem involving many thousands of variables that represent doses delivered to volume elements (voxels) in the patient. However, if the quality of angle sets can be accurately estimated without expensive computation, a large number of angle sets can be considered, increasing the likelihood of identifying a very high quality set. Using a computationally efficient surrogate beam set evaluation procedure based on single-beam data extracted from plans employing equally-spaced beams (eplans), we have developed a global search metaheuristic process based on the Nested Partitions framework for this combinatorial optimization problem. The surrogate scoring mechanism allows us to assess thousands of beam set samples within a clinically acceptable time frame. Tests on difficult clinical cases demonstrate that the beam sets obtained via our method are superior quality. PMID:23459411
The future of HIV vaccine research and the role of the Global HIV Vaccine Enterprise.

PubMed

Voronin, Yegor; Manrique, Amapola; Bernstein, Alan

2010-09-01

This review covers the role of the Global HIV Vaccine Enterprise (the Enterprise), an alliance of independent organizations committed to development of a safe and effective HIV vaccine. It discusses the history, impact on the field, and future directions and initiatives of the alliance in the context of recent progress in HIV vaccine research and development. Significant progress has been made in the field since the release of the 2005 Scientific Strategic Plan (the Plan) of the Enterprise. Over the last year, the Enterprise embarked on an impact assessment of the 2005 Plan and the development of the 2010 Plan. Enterprise Working Groups identified key priorities in the field, several of which are discussed in this review, including changing the nature, purpose and process of clinical trials, increasing and facilitating data sharing, and optimizing existing and mobilizing new resources. This time is an important moment in HIV vaccine research. New clinical trial and laboratory results have created new opportunities to advance the search for an HIV vaccine and reinvigorated the field. The Enterprise will publish its 2010 Plan this year, providing a framework for setting new priorities and directions and encouraging new and existing partners to embark on a shared scientific agenda.
Recommendations for the standardization and interpretation of the electrocardiogram. Part I: The electrocardiogram and its technology. A scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society.

PubMed

Kligfield, Paul; Gettes, Leonard S; Bailey, James J; Childers, Rory; Deal, Barbara J; Hancock, E William; van Herpen, Gerard; Kors, Jan A; Macfarlane, Peter; Mirvis, David M; Pahlm, Olle; Rautaharju, Pentti; Wagner, Galen S

2007-03-01

This statement examines the relation of the resting ECG to its technology. Its purpose is to foster understanding of how the modern ECG is derived and displayed and to establish standards that will improve the accuracy and usefulness of the ECG in practice. Derivation of representative waveforms and measurements based on global intervals are described. Special emphasis is placed on digital signal acquisition and computer-based signal processing, which provide automated measurements that lead to computer-generated diagnostic statements. Lead placement, recording methods, and waveform presentation are reviewed. Throughout the statement, recommendations for ECG standards are placed in context of the clinical implications of evolving ECG technology.
Exploration of the Medicinal Peptide Space.

PubMed

Gevaert, Bert; Stalmans, Sofie; Wynendaele, Evelien; Taevernier, Lien; Bracke, Nathalie; D'Hondt, Matthias; De Spiegeleer, Bart

2016-01-01

The chemical properties of peptide medicines, known as the 'medicinal peptide space' is considered a multi-dimensional subset of the global peptide space, where each dimension represents a chemical descriptor. These descriptors can be linked to biofunctional, medicinal properties to varying degrees. Knowledge of this space can increase the efficiency of the peptide-drug discovery and development process, as well as advance our understanding and classification of peptide medicines. For 245 peptide drugs, already available on the market or in clinical development, multivariate dataexploration was performed using peptide relevant physicochemical descriptors, their specific peptidedrug target and their clinical use. Our retrospective analysis indicates that clusters in the medicinal peptide space are located in a relatively narrow range of the physicochemical space: dense and empty regions were found, which can be explored for the discovery of novel peptide drugs.
Global collaborative healthcare: assessing the resource requirements at a leading Academic Medical Center.

PubMed

Rosson, Nicole J; Hassoun, Heitham T

2017-09-20

Academic Medical Centers ("AMCs") have served as a hub of the United States ("US") health system and represented the state-of-the art in American health care for well over a century. Currently, the global healthcare market is both massive and expanding and is being altered by the unprecedented impact of technological advances and globalization. This provides AMCs a platform to enter into trans-national collaborative partnerships with healthcare organizations around the world, thus providing a means to deliver on its promise globally while also expanding and diversifying its resources. A number of leading US AMCs have engaged in global collaborative healthcare, employing different models based on services offered, global distribution, and inclination to assume risk. Engaging in these collaborations requires significant effort from across the health system, and an understanding of the resources required is paramount for effective delivery and to avoid overextension and diversion from the primary mission of these organizations. The goal of this paper is to discuss the role of US AMCs in this current global healthcare landscape and to also investigate our institutional faculty and staff resource requirements to support the operating model. We extracted and retrospectively analyzed data from the JHI Global Services database for a 3-year period (Jan, 2013-Dec, 2015) to determine total utilization (hours and full time equivalent (FTE)), utilization by profession, and clinical and non-clinical areas of expertise. JHI utilized on average 21,940 h annually, or 10.55 FTEs of faculty and staff subject matter experts. The majority of the hours are for work performed by physician faculty members from 23 departments within the School of Medicine, representing 77% percent or on average 16,894 h annually. Clinical and allied health departments had an average annual utilization of 17,642 h or 7.8 FTEs, while non-clinical departments, schools and institutes averaged 4298 h or 1.9 FTEs, representing 80.4% and 19.6% respectively. We found that significant human resources are required within a broad range of AMC subject matter expertise across multiple disciplines, and that with adequate forecasting AMCs can successfully engage in these collaborations while continuing to fulfill their core mission.
Visual Search Targeting Either Local or Global Perceptual Processes Differs as a Function of Autistic-Like Traits in the Typically Developing Population

ERIC Educational Resources Information Center

Almeida, Renita A.; Dickinson, J. Edwin; Maybery, Murray T.; Badcock, Johanna C.; Badcock, David R.

2013-01-01

Relative to low scorers, high scorers on the Autism-Spectrum Quotient (AQ) show enhanced performance on the Embedded Figures Test and the Radial Frequency search task (RFST), which has been attributed to both enhanced local processing and differences in combining global percepts. We investigate the role of local and global processing further using…
Marriage as a Risk Factor for Internalizing Disorders: Clarifying Scope and Specificity

PubMed Central

Brock, Rebecca L.; Lawrence, Erika

2011-01-01

Objective Marital discord has been linked to both depression and anxiety; however, our understanding of how marriage contributes to the development of internalizing symptoms is limited in scope and lacking specificity. First, it is unclear whether the marital relationship contributes to the broad dimension of internalizing symptoms as opposed to specific diagnoses. Second, it is unclear how the marital relationship contributes to internalizing symptoms: through global marital dissatisfaction or through specific relationship processes (and which processes). The purpose of the present study was to address these two issues and, more generally, to develop a comprehensive and refined framework within which to understand the role of marriage in the developmental course of internalizing symptoms. Method Questionnaire and interview data were collected from 102 husbands and wives 5 times over the first 7 years of marriage. Results Results indicated that marital discord during the transition into marriage was associated with the broad dimension of internalizing symptoms for husbands but not for wives. Further, both global marital dissatisfaction and an imbalance of power and control put husbands at significant risk for symptoms over the first 7 years of marriage, whereas low levels of emotional intimacy put wives at significant risk. Conclusions Results exemplify the need to routinely consider intimate relationship processes in etiological models of depression and anxiety, and identify specific clinical targets that can be prioritized in interventions aimed at preventing internalizing disorders. PMID:21823784
SRSF2 mutations drive oncogenesis by activating a global program of aberrant alternative splicing in hematopoietic cells.

PubMed

Liang, Yang; Tebaldi, Toma; Rejeski, Kai; Joshi, Poorval; Stefani, Giovanni; Taylor, Ashley; Song, Yuanbin; Vasic, Radovan; Maziarz, Jamie; Balasubramanian, Kunthavai; Ardasheva, Anastasia; Ding, Alicia; Quattrone, Alessandro; Halene, Stephanie

2018-06-01

Recurrent mutations in the splicing factor SRSF2 are associated with poor clinical outcomes in myelodysplastic syndromes (MDS). Their high frequency suggests these mutations drive oncogenesis, yet the molecular explanation for this process is unclear. SRSF2 mutations could directly affect pre-mRNA splicing of a vital gene product; alternatively, a whole network of gene products could be affected. Here we determine how SRSF2 mutations globally affect RNA binding and splicing in vivo using HITS-CLIP. Remarkably, the majority of differential binding events do not translate into alternative splicing of exons with SRSF2 P95H binding sites. Alternative splice alterations appear to be dominated by indirect effects. Importantly, SRSF2 P95H targets are enriched in RNA processing and splicing genes, including several members of the hnRNP and SR families of proteins, suggesting a "splicing-cascade" phenotype wherein mutation of a single splicing factor leads to widespread modifications in multiple RNA processing and splicing proteins. We show that splice alteration of HNRNPA2B1, a splicing factor differentially bound and spliced by SRSF2 P95H , impairs hematopoietic differentiation in vivo. Our data suggests a model whereby the recurrent mutations in splicing factors set off a cascade of gene regulatory events that together affect hematopoiesis and drive cancer.
Clinical symptoms predict concurrent social and global functioning in an early psychosis sample.

PubMed

Cacciotti-Saija, Cristina; Langdon, Robyn; Ward, Philip B; Hickie, Ian B; Guastella, Adam J

2018-04-01

Although well established in chronic schizophrenia, the key determinants of functioning remain unknown during the early phase of a psychotic disorder. The aim of this study was to comprehensively examine the social cognitive, basic neurocognitive and clinical predictors of concurrent social functioning and global functioning in an early psychosis sample. This study examined the relationship between social cognition, basic neurocognition and clinical symptoms with concurrent functioning in 51 early psychosis individuals. Assessments included a range of self-report, observational and clinician-rated measures of cognitive, symptom severity and functioning domains. Results revealed a significant association between self-reported social function and lower levels of both social interaction anxiety and negative psychotic symptoms. A significant association was also observed between lower levels of negative psychotic symptoms and observed social functioning. Lastly, results demonstrated a significant association between reduced negative psychotic symptoms and clinician-rated global functioning. Clinical domains such as negative symptoms and social interaction anxiety significantly contribute to an optimal model predicting outcome during the early phase of a psychotic disorder. These clinical features may also provide useful markers of an individual's capacity for social participation. Clinical implications include the need for early targeted intervention to address social anxiety and negative psychotic symptoms to facilitate optimum patient outcome. © 2015 Wiley Publishing Asia Pty Ltd.
Lymphatic filariasis: patients and the global elimination programme.

PubMed

Mackenzie, C D; Lazarus, W M; Mwakitalu, M E; Mwingira, U; Malecela, M N

2009-10-01

The defining images of lymphatic filariasis are the horrendous disfigurements of lymphoedema, elephantiasis and hydrocele. These clinical presentations, although obviously important and life changing, are not, however, the only outcomes of this wide-spread filarial infection. The other effects of the disease range from severe, acute but short-term bouts of sickness to psychological impairment, poverty and family hardship. It is important to support cases of the disease through all means available, such as reparative hydrocelectomy, hygiene training and facilitation, and the provision of adequate chemotherapy. Although only a minority of the residents in any endemic community is affected with the severe clinical manifestations of this parasitic infection, these cases are central to, and important advocates for, the current global effort to eliminate the infection through mass drug administrations (MDA). Their clinical improvement acts as an important catalyst for the general population and encourages high compliance in the MDA. This communication discusses the central role that filariasis patients have played in the Tanzania Lymphatic Filariasis Elimination Programme to date, and covers some of the clinical successes achieved in the past 10 years. The abolition of the clinical manifestations of filarial infection remains the ultimate goal of the Global Programme to Eliminate Lymphatic Filariasis, and maintaining a focus on the affected individuals and their clinical condition is vital to that programme's overall success.
A web-based, patient driven registry for Angelman syndrome: the global Angelman syndrome registry.

PubMed

Napier, Kathryn R; Tones, Megan; Simons, Chloe; Heussler, Helen; Hunter, Adam A; Cross, Meagan; Bellgard, Matthew I

2017-08-01

Angelman syndrome (AS) is a rare neurodevelopmental disorder that is characterised by severe global developmental delays, ataxia, loss of speech, epilepsy, sleep disorders, and a happy disposition. There is currently no cure for AS, though several pharmaceutical companies are anticipating drug trials for new therapies to treat AS. The Foundation for Angelman Therapeutics (FAST) Australia therefore identified a need for a global AS patient registry to identify patients for recruitment for clinical trials.The Global AS Registry was deployed in September 2016 utilising the Rare Disease Registry Framework, an open-source tool that enables the efficient creation and management of patient registries. The Global AS Registry is web-based and allows parents and guardians worldwide to register, provide informed consent, and enter data on individuals with AS. 286 patients have registered in the first 8 months since deployment.We demonstrate the successful deployment of the first patient-driven global registry for AS. The data generated from the Global AS Registry will be crucial in identifying patients suitable for clinical trials and in informing research that will identify treatments for AS, and ultimately improve the lives of individuals and their families living with AS.

Lost in Translation? The Challenge of Translating the Global Education Goal and Targets into Global Indicators

ERIC Educational Resources Information Center

King, Kenneth

2017-01-01

In this article the history of global education goal- and target-setting is traced from 1990 to 2015. After the highly inclusive process of developing the Sustainable Development Goals (SDGs) and their targets, a much more technical process has produced the global indicators. The challenge of securing the ambitious targets for education in SDG 4…
Assessment of global longitudinal strain using standardized myocardial deformation imaging: a modality independent software approach.

PubMed

Riffel, Johannes H; Keller, Marius G P; Aurich, Matthias; Sander, Yannick; Andre, Florian; Giusca, Sorin; Aus dem Siepen, Fabian; Seitz, Sebastian; Galuschky, Christian; Korosoglou, Grigorios; Mereles, Derliz; Katus, Hugo A; Buss, Sebastian J

2015-07-01

Myocardial deformation measurement is superior to left ventricular ejection fraction in identifying early changes in myocardial contractility and prediction of cardiovascular outcome. The lack of standardization hinders its clinical implementation. The aim of the study is to investigate a novel standardized deformation imaging approach based on the feature tracking algorithm for the assessment of global longitudinal (GLS) and global circumferential strain (GCS) in echocardiography and cardiac magnetic resonance imaging (CMR). 70 subjects undergoing CMR were consecutively investigated with echocardiography within a median time of 30 min. GLS and GCS were analyzed with a post-processing software incorporating the same standardized algorithm for both modalities. Global strain was defined as the relative shortening of the whole endocardial contour length and calculated according to the strain formula. Mean GLS values were -16.2 ± 5.3 and -17.3 ± 5.3 % for echocardiography and CMR, respectively. GLS did not differ significantly between the two imaging modalities, which showed strong correlation (r = 0.86), a small bias (-1.1 %) and narrow 95 % limits of agreement (LOA ± 5.4 %). Mean GCS values were -17.9 ± 6.3 and -24.4 ± 7.8 % for echocardiography and CMR, respectively. GCS was significantly underestimated by echocardiography (p < 0.001). A weaker correlation (r = 0.73), a higher bias (-6.5 %) and wider LOA (± 10.5 %) were observed for GCS. GLS showed a strong correlation (r = 0.92) when image quality was good, while correlation dropped to r = 0.82 with poor acoustic windows in echocardiography. GCS assessment revealed only a strong correlation (r = 0.87) when echocardiographic image quality was good. No significant differences for GLS between two different echocardiographic vendors could be detected. Quantitative assessment of GLS using a standardized software algorithm allows the direct comparison of values acquired irrespective of the imaging modality. GLS may, therefore, serve as a reliable parameter for the assessment of global left ventricular function in clinical routine besides standard evaluation of the ejection fraction.
True communication skills assessment in interdepartmental OSCE stations: Standard setting using the MAAS-Global and EduG.

PubMed

Setyonugroho, Winny; Kropmans, Thomas; Murphy, Ruth; Hayes, Peter; van Dalen, Jan; Kennedy, Kieran M

2018-01-01

Comparing outcome of clinical skills assessment is challenging. This study proposes reliable and valid comparison of communication skills (1) assessment as practiced in Objective Structured Clinical Examinations (2). The aim of the present study is to compare CS assessment, as standardized according to the MAAS Global, between stations in a single undergraduate medical year. An OSCE delivered in an Irish undergraduate curriculum was studied. We chose the MAAS-Global as an internationally recognized and validated instrument to calibrate the OSCE station items. The MAAS-Global proportion is the percentage of station checklist items that can be considered as 'true' CS. The reliability of the OSCE was calculated with G-Theory analysis and nested ANOVA was used to compare mean scores of all years. MAAS-Global scores in psychiatry stations were significantly higher than those in other disciplines (p<0.03) and above the initial pass mark of 50%. The higher students' scores in psychiatry stations were related to higher MAAS-Global proportions when compared to the general practice stations. Comparison of outcome measurements, using the MAAS Global as a standardization instrument, between interdisciplinary station checklists was valid and reliable. The MAAS-Global was used as a single validated instrument and is suggested as gold standard. Copyright © 2017. Published by Elsevier B.V.
Global health training in US graduate psychiatric education.

PubMed

Tsai, Alexander C; Fricchione, Gregory L; Walensky, Rochelle P; Ng, Courtney; Bangsberg, David R; Kerry, Vanessa B

2014-08-01

Global health training opportunities have figured prominently into medical students' residency program choices across a range of clinical specialties. To date, however, the national scope of global mental health education has not heretofore been systematically assessed. We therefore sought to characterize the distribution of global health training opportunities in US graduate psychiatric education. We examined the web pages of all US psychiatry residency training programs, along with search results from a systematic Google query designed to identify global health training opportunities. Of the 183 accredited US psychiatry residency programs, we identified 17 programs (9.3%) offering 28 global health training opportunities in 64 countries. Ten psychiatry residency programs offered their residents opportunities to participate in one or more elective-based rotations, eight offered research activities, and six offered extended field-based training. Most global health training opportunities occurred within the context of externally administered, institution-wide initiatives generally available to residents from a range of clinical specialties, rather than within internally administered departmental initiatives specifically tailored for psychiatry residents. There are relatively few global health training opportunities in US graduate psychiatric education. These activities have a clear role in enhancing mastery of Accreditation Council for Graduate Medical Education core competencies, but important challenges related to program funding and evaluation remain.
Global Health Training in U.S. Graduate Psychiatric Education

PubMed Central

Tsai, Alexander; Fricchione, Gregory; Walensky, Rochelle; Ng, Courtney; Bangsberg, David; Kerry, Vanessa

2014-01-01

Objective Global health training opportunities have figured prominently into medical students’ residency program choices across a range of clinical specialties. To date, however, the national scope of global mental health education has not heretofore been systematically assessed. We therefore sought to characterize the distribution of global health training opportunities in U.S. graduate psychiatric education. Methods We examined the web pages of all U.S. psychiatry residency training programs, along with search results from a systematic Google query designed to identify global health training opportunities. Results Of the 183 accredited U.S. psychiatry residency programs, we identified 17 programs (9.3%) offering 28 global health training opportunities in 64 countries. Ten psychiatry residency programs offered their residents opportunities to participate in one or more elective-based rotations, eight offered research activities, and six offered extended field-based training. Most global health training opportunities occurred within the context of externally administered, institution-wide initiatives generally available to residents from a range of clinical specialties, rather than within internally administered departmental initiatives specifically tailored for psychiatry residents. Conclusions There are relatively few global health training opportunities in U.S. graduate psychiatric education. These activities have a clear role in enhancing mastery of Accreditation Council for Graduate Medical Education core competencies, but important challenges related to program funding and evaluation remain. PMID:24664609
Opening our hearts and minds: the meaning of international clinical nursing electives in the personal and professional lives of nurses.

PubMed

Callister, Lynn Clark; Cox, Amy Harmer

2006-06-01

Although international opportunities are the hallmark of nursing education at a large private university, the meaning of participating in such clinical nursing electives has not been described. The purpose of this phenomenological study of nurses was to examine the personal and professional meaning of participating in international clinical nursing electives during their undergraduate nursing studies. Audiotaped interviews were conducted with 20 former nursing students who had had this opportunity. "Opening our hearts and minds" was described by the study's participants, with the following themes: increasing understanding of other cultures and peoples, increasing understanding of global sociopolitical and health issues, increasing the commitment to make a difference, experiencing personal and professional growth, contributing to professional development in the host country, making interpersonal connexions, and developing cultural competence. This study makes an important contribution to the documentation of the meaning of participating in international nursing clinical experiences. Data are being used for long-term curricular planning in the development and refinement of future international clinical nursing electives and to provide outcomes data for professional accreditation. There are broader implications for the movement beyond individual cultural competence to increasing global consciousness and the improvement of global health care.
Motor, cognitive, and functional declines contribute to a single progressive factor in early HD.

PubMed

Schobel, Scott A; Palermo, Giuseppe; Auinger, Peggy; Long, Jeffrey D; Ma, Shiyang; Khwaja, Omar S; Trundell, Dylan; Cudkowicz, Merit; Hersch, Steven; Sampaio, Cristina; Dorsey, E Ray; Leavitt, Blair R; Kieburtz, Karl D; Sevigny, Jeffrey J; Langbehn, Douglas R; Tabrizi, Sarah J

2017-12-12

To identify an improved measure of clinical progression in early Huntington disease (HD) using data from prospective observational cohort studies and placebo group data from randomized double-blind clinical trials. We studied Unified Huntington Disease Rating Scale (UHDRS) and non-UHDRS clinical measures and brain measures of progressive atrophy in 1,668 individuals with early HD followed up prospectively for up to 30 to 36 months of longitudinal clinical follow-up. The results demonstrated that a composite measure of motor, cognitive, and global functional decline best characterized clinical progression and was most strongly associated with brain measures of progressive corticostriatal atrophy. Use of a composite motor, cognitive, and global functional clinical outcome measure in HD provides an improved measure of clinical progression more related to measures of progressive brain atrophy and provides an opportunity for enhanced clinical trial efficiency relative to currently used individual motor, cognitive, and functional outcome measures. © 2017 American Academy of Neurology.
Can the FDA improve oversight of foreign clinical trials?: Closing the information gap and moving towards a globalized regulatory scheme.

PubMed

Ourso, André

2012-01-01

Currently, pharmaceutical companies' utilization of foreign clinical trial data is a ubiquitous and indispensable aspect of gaining approval to market drugs in the United States. Cost benefits, a larger pool of ready volunteer subjects, and greater efficiency in clinical testing are some of the reasons for conducting clinical trials overseas. Despite these advantages, lack of proper oversight may have serious public health implications regarding the integrity of clinical research, ethical treatment of human subjects, and drug safety. Due to the expansive global nature of foreign clinical trials, there are concerns with the FDA's ability to monitor and regulate these trials. This article examines the FDA's oversight of foreign clinical trials and the agency's limitations regulating these trials. In addition to looking at steps the FDA is taking to address these limitations, the article examines other potential regulatory and cooperative actions that can be taken to effectively monitor foreign clinical trials and to ensure data integrity and patient safety.
Sampling capacity underlies individual differences in human associative learning.

PubMed

Byrom, Nicola C; Murphy, Robin A

2014-04-01

Though much work has studied how external factors, such as stimulus properties, influence generalization of associative strength, there has been limited exploration of the influence that internal dispositions may contribute to stimulus processing. Here we report 2 studies using a modified negative patterning discrimination to test the relationship between global processing and generalization. Global processing was associated with stronger negative patterning discrimination, indicative of limited generalization between distinct stimulus compounds and their constituent elements. In Experiment 2, participants pretrained to adopt global processing similarly showed strong negative patterning discrimination. These results demonstrate considerable individual difference in capacity to engage in negative patterning discrimination and suggest that the tendency toward global processing may be one factor explaining this variability. The need for models of learning to account for this variability in learning is discussed.
Evaluation of high fidelity patient simulator in assessment of performance of anaesthetists.

PubMed

Weller, J M; Bloch, M; Young, S; Maze, M; Oyesola, S; Wyner, J; Dob, D; Haire, K; Durbridge, J; Walker, T; Newble, D

2003-01-01

There is increasing emphasis on performance-based assessment of clinical competence. The High Fidelity Patient Simulator (HPS) may be useful for assessment of clinical practice in anaesthesia, but needs formal evaluation of validity, reliability, feasibility and effect on learning. We set out to assess the reliability of a global rating scale for scoring simulator performance in crisis management. Using a global rating scale, three judges independently rated videotapes of anaesthetists in simulated crises in the operating theatre. Five anaesthetists then independently rated subsets of these videotapes. There was good agreement between raters for medical management, behavioural attributes and overall performance. Agreement was high for both the initial judges and the five additional raters. Using a global scale to assess simulator performance, we found good inter-rater reliability for scoring performance in a crisis. We estimate that two judges should provide a reliable assessment. High fidelity simulation should be studied further for assessing clinical performance.
Training pediatric clinical pharmacology and therapeutics specialists of the future: the needs, the reality, and opportunities for international networking.

PubMed

Gazarian, Madlen

2009-01-01

In recent years there has been a rapid and marked increase in global recognition of the need for better medicines for children, with various initiatives being implemented at global and regional levels. These exciting developments are matched by recognition of the need to build greater capacity in the field of pediatric clinical pharmacology and therapeutics to help deliver on the promise of better medicines for children. A range of pediatric medicines researchers, educators, clinical therapeutics practitioners, and experts in drug evaluation, regulation, and broader medicines policy are needed on a larger scale, in both developed and developing world settings. The current and likely future training needs to meet these diverse challenges, the current realities of trying to meet such needs, and the opportunities for international networking to help meet future training needs are discussed from a global perspective.
Integrating Genome-based Informatics to Modernize Global Disease Monitoring, Information Sharing, and Response

PubMed Central

Brown, Eric W.; Detter, Chris; Gerner-Smidt, Peter; Gilmour, Matthew W.; Harmsen, Dag; Hendriksen, Rene S.; Hewson, Roger; Heymann, David L.; Johansson, Karin; Ijaz, Kashef; Keim, Paul S.; Koopmans, Marion; Kroneman, Annelies; Wong, Danilo Lo Fo; Lund, Ole; Palm, Daniel; Sawanpanyalert, Pathom; Sobel, Jeremy; Schlundt, Jørgen

2012-01-01

The rapid advancement of genome technologies holds great promise for improving the quality and speed of clinical and public health laboratory investigations and for decreasing their cost. The latest generation of genome DNA sequencers can provide highly detailed and robust information on disease-causing microbes, and in the near future these technologies will be suitable for routine use in national, regional, and global public health laboratories. With additional improvements in instrumentation, these next- or third-generation sequencers are likely to replace conventional culture-based and molecular typing methods to provide point-of-care clinical diagnosis and other essential information for quicker and better treatment of patients. Provided there is free-sharing of information by all clinical and public health laboratories, these genomic tools could spawn a global system of linked databases of pathogen genomes that would ensure more efficient detection, prevention, and control of endemic, emerging, and other infectious disease outbreaks worldwide. PMID:23092707
Peace in the Clinic: Rethinking "Global Health Diplomacy" in the Somali Region of Ethiopia.

PubMed

Carruth, Lauren

2016-06-01

Drawing on ethnographic research with Somalis, within aid organizations, and within health care facilities in the Somali Region of Ethiopia, this article argues that what is called "global health diplomacy," despite its origins and articulations in interstate politics, is fundamentally local and interpersonal. As evidence, I outline two very different health programs in the Somali Region of Ethiopia, and how, in each, existing animosities and political grievances were either reinforced or undermined. I argue that the provision of health care in politically insecure and post-conflict settings like the Somali Region of Ethiopia is precarious but pivotal: medical encounters have the potential to either worsen the conditions in which conflicts and crises recur, or build new interpersonal and governmental relations of trust. Effective global health diplomacy, therefore, cannot be limited to building clinics and donating medicine, but must also explicitly include building positive relationships of trust between oppositional groups within clinical spaces.
Recognizing the bank robber and spotting the difference: emotional state and global vs. local attentional set.

PubMed

Pacheco-Unguetti, Antonia Pilar; Acosta, Alberto; Lupiáñez, Juan

2014-01-01

In two experiments (161 participants in total), we investigated how current mood influences processing styles (global vs. local). Participants watched a video of a bank robbery before receiving a positive, negative or neutral induction, and they performed two tasks: a face-recognition task about the bank robber as global processing measure, and a spot-the-difference task using neutral pictures (Experiment-1) or emotional scenes (Experiment-2) as local processing measure. Results showed that positive mood induction favoured a global processing style, enhancing participants' ability to correctly identify a face even when they watched the video before the mood-induction. This shows that, besides influencing encoding processes, mood state can be also related to retrieval processes. On the contrary, negative mood induction enhanced a local processing style, making easier and faster the detection of differences between nearly identical pictures, independently of their valence. This dissociation supports the hypothesis that current mood modulates processing through activation of different cognitive styles.
Adapting public policy theory for public health research: A framework to understand the development of national policies on global health.

PubMed

Jones, Catherine M; Clavier, Carole; Potvin, Louise

2017-03-01

National policies on global health appear as one way that actors from health, development and foreign affairs sectors in a country coordinate state action on global health. Next to a burgeoning literature in which international relations and global governance theories are employed to understand global health policy and global health diplomacy at the international level, little is known about policy processes for global health at the national scale. We propose a framework of the policy process to understand how such policies are developed, and we identify challenges for public health researchers integrating conceptual tools from political science. We developed the framework using a two-step process: 1) reviewing literature to establish criteria for selecting a theoretical framework fit for this purpose, and 2) adapting Real-Dato's synthesis framework to integrate a cognitive approach to public policy within a constructivist perspective. Our framework identifies multiple contexts as part of the policy process, focuses on situations where actors work together to make national policy on global health, considers these interactive situations as spaces for observing external influences on policy change and proposes policy design as the output of the process. We suggest that this framework makes three contributions to the conceptualisation of national policy on global health as a research object. First, it emphasizes collective action over decisions of individual policy actors. Second, it conceptualises the policy process as organised interactive spaces for collaboration rather than as stages of a policy cycle. Third, national decision-making spaces are opportunities for transferring ideas and knowledge from different sectors and settings, and represent opportunities to identify international influences on a country's global health policy. We discuss two sets of challenges for public health researchers using interdisciplinary approaches in policy research. Copyright © 2017 Elsevier Ltd. All rights reserved.
Improving Global Health Education: Development of a Global Health Competency Model

PubMed Central

Ablah, Elizabeth; Biberman, Dorothy A.; Weist, Elizabeth M.; Buekens, Pierre; Bentley, Margaret E.; Burke, Donald; Finnegan, John R.; Flahault, Antoine; Frenk, Julio; Gotsch, Audrey R.; Klag, Michael J.; Lopez, Mario Henry Rodriguez; Nasca, Philip; Shortell, Stephen; Spencer, Harrison C.

2014-01-01

Although global health is a recommended content area for the future of education in public health, no standardized global health competency model existed for master-level public health students. Without such a competency model, academic institutions are challenged to ensure that students are able to demonstrate the knowledge, skills, and attitudes (KSAs) needed for successful performance in today's global health workforce. The Association of Schools of Public Health (ASPH) sought to address this need by facilitating the development of a global health competency model through a multistage modified-Delphi process. Practitioners and academic global health experts provided leadership and guidance throughout the competency development process. The resulting product, the Global Health Competency Model 1.1, includes seven domains and 36 competencies. The Global Health Competency Model 1.1 provides a platform for engaging educators, students, and global health employers in discussion of the KSAs needed to improve human health on a global scale. PMID:24445206
Improving washing strategies of human mesenchymal stem cells using negative mode expanded bed chromatography.

PubMed

Cunha, Bárbara; Silva, Ricardo J S; Aguiar, Tiago; Serra, Margarida; Daicic, John; Maloisel, Jean-Luc; Clachan, John; Åkerblom, Anna; Carrondo, Manuel J T; Peixoto, Cristina; Alves, Paula M

2016-01-15

The use of human mesenchymal stem cells (hMSC) in clinical applications has been increasing over the last decade. However, to be applied in a clinical setting hMSC need to comply with specific requirements in terms of identity, potency and purity. This study reports the improvement of established tangential flow filtration (TFF)-based washing strategies, further increasing hMSC purity, using negative mode expanded bed adsorption (EBA) chromatography with a new multimodal prototype matrix based on core-shell bead technology. The matrix was characterized and a stable, expanded bed could be obtained using standard equipment adapted from what is used for conventional packed bed chromatography processes. The effect of different expansion rates on cell recovery yield and protein removal capacity was assessed. The best trade-off between cell recovery (89%) and protein clearance (67%) was achieved using an intermediate expansion bed rate (1.4). Furthermore, we also showed that EBA chromatography can be efficiently integrated on the already established process for the downstream processing (DSP) of hMSC, where it improved the washing efficiency more than 10-fold, recovering approximately 70% of cells after global processing. This strategy showed not to impact cell viability (>95%), neither hMSC's characteristics in terms of morphology, immunophenotype, proliferation, adhesion capacity and multipotent differentiation potential. Copyright © 2015 Elsevier B.V. All rights reserved.
Promoting the self-regulation of clinical reasoning skills in nursing students.

PubMed

Kuiper, R; Pesut, D; Kautz, D

2009-10-02

The purpose of this paper is to describe the research surrounding the theories and models the authors united to describe the essential components of clinical reasoning in nursing practice education. The research was conducted with nursing students in health care settings through the application of teaching and learning strategies with the Self-Regulated Learning Model (SRL) and the Outcome-Present-State-Test (OPT) Model of Reflective Clinical Reasoning. Standardized nursing languages provided the content and clinical vocabulary for the clinical reasoning task. This descriptive study described the application of the OPT model of clinical reasoning, use of nursing language content, and reflective journals based on the SRL model with 66 undergraduate nursing students over an 8 month period of time. The study tested the idea that self-regulation of clinical reasoning skills can be developed using self-regulation theory and the OPT model. This research supports a framework for effective teaching and learning methods to promote and document learner progress in mastering clinical reasoning skills. Self-regulated Learning strategies coupled with the OPT model suggest benefits of self-observation and self-monitoring during clinical reasoning activities, and pinpoints where guidance is needed for the development of cognitive and metacognitive awareness. Thinking and reasoning about the complexities of patient care needs requires attention to the content, processes and outcomes that make a nursing care difference. These principles and concepts are valuable to clinical decision making for nurses globally as they deal with local, regional, national and international health care issues.
Subthalamic stimulation modulates cortical motor network activity and synchronization in Parkinson's disease.

PubMed

Weiss, Daniel; Klotz, Rosa; Govindan, Rathinaswamy B; Scholten, Marlieke; Naros, Georgios; Ramos-Murguialday, Ander; Bunjes, Friedemann; Meisner, Christoph; Plewnia, Christian; Krüger, Rejko; Gharabaghi, Alireza

2015-03-01

Dynamic modulations of large-scale network activity and synchronization are inherent to a broad spectrum of cognitive processes and are disturbed in neuropsychiatric conditions including Parkinson's disease. Here, we set out to address the motor network activity and synchronization in Parkinson's disease and its modulation with subthalamic stimulation. To this end, 20 patients with idiopathic Parkinson's disease with subthalamic nucleus stimulation were analysed on externally cued right hand finger movements with 1.5-s interstimulus interval. Simultaneous recordings were obtained from electromyography on antagonistic muscles (right flexor digitorum and extensor digitorum) together with 64-channel electroencephalography. Time-frequency event-related spectral perturbations were assessed to determine cortical and muscular activity. Next, cross-spectra in the time-frequency domain were analysed to explore the cortico-cortical synchronization. The time-frequency modulations enabled us to select a time-frequency range relevant for motor processing. On these time-frequency windows, we developed an extension of the phase synchronization index to quantify the global cortico-cortical synchronization and to obtain topographic differentiations of distinct electrode sites with respect to their contributions to the global phase synchronization index. The spectral measures were used to predict clinical and reaction time outcome using regression analysis. We found that movement-related desynchronization of cortical activity in the upper alpha and beta range was significantly facilitated with 'stimulation on' compared to 'stimulation off' on electrodes over the bilateral parietal, sensorimotor, premotor, supplementary-motor, and prefrontal areas, including the bilateral inferior prefrontal areas. These spectral modulations enabled us to predict both clinical and reaction time improvement from subthalamic stimulation. With 'stimulation on', interhemispheric cortico-cortical coherence in the beta band was significantly attenuated over the bilateral sensorimotor areas. Similarly, the global cortico-cortical phase synchronization was attenuated, and the topographic differentiation revealed stronger desynchronization over the (ipsilateral) right-hemispheric prefrontal, premotor and sensorimotor areas compared to 'stimulation off'. We further demonstrated that the cortico-cortical phase synchronization was largely dominated by genuine neuronal coupling. The clinical improvement with 'stimulation on' compared to 'stimulation off' could be predicted from this cortical decoupling with multiple regressions, and the reduction of synchronization over the right prefrontal area showed a linear univariate correlation with clinical improvement. Our study demonstrates wide-spread activity and synchronization modulations of the cortical motor network, and highlights subthalamic stimulation as a network-modulating therapy. Accordingly, subthalamic stimulation may release bilateral cortical computational resources by facilitating movement-related desynchronization. Moreover, the subthalamic nucleus is critical to balance inhibitory and facilitatory cortical players within the motor program. © The Author (2015). Published by Oxford University Press on behalf of the Guarantors of Brain. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
Subthalamic stimulation modulates cortical motor network activity and synchronization in Parkinson’s disease

PubMed Central

Klotz, Rosa; Govindan, Rathinaswamy B.; Scholten, Marlieke; Naros, Georgios; Ramos-Murguialday, Ander; Bunjes, Friedemann; Meisner, Christoph; Plewnia, Christian; Krüger, Rejko

2015-01-01

Dynamic modulations of large-scale network activity and synchronization are inherent to a broad spectrum of cognitive processes and are disturbed in neuropsychiatric conditions including Parkinson’s disease. Here, we set out to address the motor network activity and synchronization in Parkinson’s disease and its modulation with subthalamic stimulation. To this end, 20 patients with idiopathic Parkinson’s disease with subthalamic nucleus stimulation were analysed on externally cued right hand finger movements with 1.5-s interstimulus interval. Simultaneous recordings were obtained from electromyography on antagonistic muscles (right flexor digitorum and extensor digitorum) together with 64-channel electroencephalography. Time-frequency event-related spectral perturbations were assessed to determine cortical and muscular activity. Next, cross-spectra in the time-frequency domain were analysed to explore the cortico-cortical synchronization. The time-frequency modulations enabled us to select a time-frequency range relevant for motor processing. On these time-frequency windows, we developed an extension of the phase synchronization index to quantify the global cortico-cortical synchronization and to obtain topographic differentiations of distinct electrode sites with respect to their contributions to the global phase synchronization index. The spectral measures were used to predict clinical and reaction time outcome using regression analysis. We found that movement-related desynchronization of cortical activity in the upper alpha and beta range was significantly facilitated with ‘stimulation on’ compared to ‘stimulation off’ on electrodes over the bilateral parietal, sensorimotor, premotor, supplementary-motor, and prefrontal areas, including the bilateral inferior prefrontal areas. These spectral modulations enabled us to predict both clinical and reaction time improvement from subthalamic stimulation. With ‘stimulation on’, interhemispheric cortico-cortical coherence in the beta band was significantly attenuated over the bilateral sensorimotor areas. Similarly, the global cortico-cortical phase synchronization was attenuated, and the topographic differentiation revealed stronger desynchronization over the (ipsilateral) right-hemispheric prefrontal, premotor and sensorimotor areas compared to ‘stimulation off’. We further demonstrated that the cortico-cortical phase synchronization was largely dominated by genuine neuronal coupling. The clinical improvement with ‘stimulation on’ compared to ‘stimulation off’ could be predicted from this cortical decoupling with multiple regressions, and the reduction of synchronization over the right prefrontal area showed a linear univariate correlation with clinical improvement. Our study demonstrates wide-spread activity and synchronization modulations of the cortical motor network, and highlights subthalamic stimulation as a network-modulating therapy. Accordingly, subthalamic stimulation may release bilateral cortical computational resources by facilitating movement-related desynchronization. Moreover, the subthalamic nucleus is critical to balance inhibitory and facilitatory cortical players within the motor program. PMID:25558877

Effects of early focal brain injury on memory for visuospatial patterns: selective deficits of global-local processing.

PubMed

Stiles, Joan; Stern, Catherine; Appelbaum, Mark; Nass, Ruth; Trauner, Doris; Hesselink, John

2008-01-01

Selective deficits in visuospatial processing are present early in development among children with perinatal focal brain lesions (PL). Children with right hemisphere PL (RPL) are impaired in configural processing, while children with left hemisphere PL (LPL) are impaired in featural processing. Deficits associated with LPL are less pervasive than those observed with RPL, but this difference may reflect the structure of the tasks used for assessment. Many of the tasks used to date may place greater demands on configural processing, thus highlighting this deficit in the RPL group. This study employed a task designed to place comparable demands on configural and featural processing, providing the opportunity to obtain within-task evidence of differential deficit. Sixty-two 5- to 14-year-old children (19 RPL, 19 LPL, and 24 matched controls) reproduced from memory a series of hierarchical forms (large forms composed of small forms). Global- and local-level reproduction accuracy was scored. Controls were equally accurate on global- and local-level reproduction. Children with RPL were selectively impaired on global accuracy, and children with LPL on local accuracy, thus documenting a double dissociation in global-local processing.
A Hough Transform Global Probabilistic Approach to Multiple-Subject Diffusion MRI Tractography

DTIC Science & Technology

2010-04-01

distribution unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT A global probabilistic fiber tracking approach based on the voting process provided by...umn.edu 2 ABSTRACT A global probabilistic fiber tracking approach based on the voting process provided by the Hough transform is introduced in...criteria for aligning curves and particularly tracts. In this work, we present a global probabilistic approach inspired by the voting procedure provided
On Becoming a Global Citizen: Transformative Learning Through Global Health Experiences.

PubMed

Litzelman, Debra K; Gardner, Adrian; Einterz, Robert M; Owiti, Philip; Wambui, Charity; Huskins, Jordan C; Schmitt-Wendholt, Kathleen M; Stone, Geren S; Ayuo, Paul O; Inui, Thomas S; Umoren, Rachel A

Globalization has increased the demand for international experiences in medical education. International experiences improve medical knowledge, clinical skills, and self-development; influence career objectives; and provide insights on ethical and societal issues. However, global health rotations can end up being no more than tourism if not structured to foster personal transformation and global citizenship. We conducted a qualitative assessment of trainee-reported critical incidents to more deeply understand the impact of our global health experience on trainees. A cross-sectional survey was administered to trainees who had participated in a 2-month elective in Kenya from January 1989 to May 2013. We report the results of a qualitative assessment of the critical incident reflections participants (n = 137) entered in response to the prompt, "Write about one of your most memorable experiences and explain why you chose to describe this particular one." Qualitative analyses were conducted using thematic analysis and crystallization immersion analytic methods based on the principles of grounded theory, employing a constructivists' research paradigm. Four major themes emerged. These themes were Opening Oneself to a Broader World View; Impact of Suffering and Death; Life-Changing Experiences; and Commitment to Care for the Medically Underserved. Circumstances that learners encounter in the resource-scarce environment in Kenya are eye-opening and life-changing. When exposed to these frame-shifting circumstances, students elaborate on or transform existing points of view. These emotionally disruptive experiences in an international health setting allowed students to enter a transformational learning process with a global mind. Students can see the world as an interdependent society and develop the capacity to advance both their enlightened self-interest and the interest of people elsewhere in the world as they mature as global citizens. Medical schools are encouraged to foster these experiences by finding ways to integrate them into curriculum. Copyright © 2017 Icahn School of Medicine at Mount Sinai. Published by Elsevier Inc. All rights reserved.
Sex differences in the Kimchi-Palmer task revisited: Global reaction times, but not number of global choices differ between adult men and women.

PubMed

Scheuringer, Andrea; Pletzer, Belinda

2016-10-15

Research, directly assessing sex-dependent differences in global versus local processing is sparse, but predominantly suggesting that men show a stronger global processing bias than women. Utilizing the Kimchi-Palmer task however, sex differences in the number of global choices can only be found in children, but not in adults. In the current study 52 men and 46 women completed a computerized version of the Kimchi Palmer task, in order to investigate whether sex-differences in global-local processing in the Kimchi-Palmer task are reflected in choice reaction times rather than choices per se. While no sex differences were found in the number of global choices, we found that especially women are faster in making local choices than men, while men are faster in making global choices than women. We did not find support for the assumption that this sex difference was modulated by menstrual cycle phase of women, since the difference between reaction times to global and local choices was consistent across the menstrual cycle of women. Accordingly there was no relationship between progesterone and global-local processing in the Kimchi-Palmer task. However, like in studies utilizing the Navon task, testosterone was positively related to the number of global choices in both men and women. To our knowledge, this is the first study including reaction times as outcome measure in a Kimchi Palmer paradigm and also the first study demonstrating sex differences in the Kimchi Palmer task in adults. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
Modulation of Global and Local Processing Biases in Adults with Autistic-Like Traits

ERIC Educational Resources Information Center

English, Michael C. W.; Maybery, Murray T.; Visser, Troy A. W.

2017-01-01

Previous work shows that doing a continuous performance task (CPT) shifts attentional biases in neurotypical individuals towards global aspects of hierarchical Navon figures by selectively activating right hemisphere regions associated with global processing. The present study examines whether CPT can induce similar modulations of attention in…
Global Polity in Adult Education and UNESCO: Landmarking, Brokering and Framing Policy

ERIC Educational Resources Information Center

Milana, Marcella

2016-01-01

Aknowledging the complexity of local-global interconnections, the author argues for the adoption of a global polity perspective in adult education, here applied to study mobilisation processes that occur through UNESCO. The findings point to three processes that cross geopolitical borders and professional interests: "landmarking," by…
Estimating multi-period global cost efficiency and productivity change of systems with network structures

NASA Astrophysics Data System (ADS)

Tohidnia, S.; Tohidi, G.

2018-02-01

The current paper develops three different ways to measure the multi-period global cost efficiency for homogeneous networks of processes when the prices of exogenous inputs are known at all time periods. A multi-period network data envelopment analysis model is presented to measure the minimum cost of the network system based on the global production possibility set. We show that there is a relationship between the multi-period global cost efficiency of network system and its subsystems, and also its processes. The proposed model is applied to compute the global cost Malmquist productivity index for measuring the productivity changes of network system and each of its process between two time periods. This index is circular. Furthermore, we show that the productivity changes of network system can be defined as a weighted average of the process productivity changes. Finally, a numerical example will be presented to illustrate the proposed approach.
Dosimetric validation and clinical implementation of two 3D dose verification systems for quality assurance in volumetric-modulated arc therapy techniques.

PubMed

Clemente-Gutiérrez, Francisco; Pérez-Vara, Consuelo

2015-03-08

A pretreatment quality assurance program for volumetric techniques should include redundant calculations and measurement-based verifications. The patient-specific quality assurance process must be based in clinically relevant metrics. The aim of this study was to show the commission, clinical implementation, and comparison of two systems that allow performing a 3D redundant dose calculation. In addition, one of them is capable of reconstructing the dose on patient anatomy from measurements taken with a 2D ion chamber array. Both systems were compared in terms of reference calibration data (absolute dose, output factors, percentage depth-dose curves, and profiles). Results were in good agreement for absolute dose values (discrepancies were below 0.5%) and output factors (mean differences were below 1%). Maximum mean discrepancies were located between 10 and 20 cm of depth for PDDs (-2.7%) and in the penumbra region for profiles (mean DTA of 1.5 mm). Validation of the systems was performed by comparing point-dose measurements with values obtained by the two systems for static, dynamic fields from AAPM TG-119 report, and 12 real VMAT plans for different anatomical sites (differences better than 1.2%). Comparisons between measurements taken with a 2D ion chamber array and results obtained by both systems for real VMAT plans were also performed (mean global gamma passing rates better than 87.0% and 97.9% for the 2%/2 mm and 3%/3 mm criteria). Clinical implementation of the systems was evaluated by comparing dose-volume parameters for all TG-119 tests and real VMAT plans with TPS values (mean differences were below 1%). In addition, comparisons between dose distributions calculated by TPS and those extracted by the two systems for real VMAT plans were also performed (mean global gamma passing rates better than 86.0% and 93.0% for the 2%/2 mm and 3%/ 3 mm criteria). The clinical use of both systems was successfully evaluated.
Building Networks for Global Clinical Research: The Basics.

PubMed

Shearer, David W; Volberding, Paul A; Schemitsch, Emil H; Cook, Gillian E; Slobogean, Gerard P; Morshed, Saam

2015-12-01

Over the last several decades, interest in global health across all fields of medicine, including orthopaedic surgery, has grown markedly. Cross-national collaborations are an effective means of conducting high-quality clinical research and offer many advantages over single-center investigations. Successful collaboration requires a well-designed research protocol, development of an effective team structure, and the funding to ensure the project is sustained to completion. Equally important, investigators must consider the social, linguistic, and cultural context in which the study is being undertaken. Although randomized clinical trials are the highest level of evidence, study designs may have to be adapted to accommodate available resources, expertise, and local contextual factors. With appropriate planning, these collaborative endeavors can generate changes in clinical practice and positively impact health policy.
Cognition, glucose metabolism and amyloid burden in Alzheimer’s disease

PubMed Central

Furst, Ansgar J.; Rabinovici, Gil D.; Rostomian, Ara H.; Steed, Tyler; Alkalay, Adi; Racine, Caroline; Miller, Bruce L.; Jagust, William J.

2010-01-01

We investigated relationships between glucose metabolism, amyloid load and measures of cognitive and functional impairment in Alzheimer’s disease (AD). Patients meeting criteria for probable AD underwent [11C]PIB and [18F]FDG PET imaging and were assessed on a set of clinical measures. PIB Distribution volume ratios and FDG scans were spatially normalized and average PIB counts from regions-of-interest (ROI) were used to compute a measure of global PIB uptake. Separate voxel-wise regressions explored local and global relationships between metabolism, amyloid burden and clinical measures. Regressions reflected cognitive domains assessed by individual measures, with visuospatial tests associated with more posterior metabolism, and language tests associated with metabolism in the left hemisphere. Correlating regional FDG uptake with these measures confirmed these findings. In contrast, no correlations were found between either voxel-wise or regional PIB uptake and any of the clinical measures. Finally, there were no associations between regional PIB and FDG uptake. We conclude that regional and global amyloid burden does not correlate with clinical status or glucose metabolism in AD. PMID:20417582
Global Influenza Surveillance at AFIOH (Briefing Slides)

DTIC Science & Technology

2006-12-19

Air Force Institute for Operational Health (AFIOH) Birthplace, Home, and Future of Aerospace Medicine Global Influenza Surveillance at AFIOH 19 Dec...COVERED 00-00-2006 to 00-00-2006 4. TITLE AND SUBTITLE Global Influenza Surveillance at AFIOH 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM...clinics and hospitals around the world Expanded efforts in 1997 • DoD Global Laboratory-Based Influenza Surveillance Program • AF designated as the
Sampling Capacity Underlies Individual Differences in Human Associative Learning

PubMed Central

2014-01-01

Though much work has studied how external factors, such as stimulus properties, influence generalization of associative strength, there has been limited exploration of the influence that internal dispositions may contribute to stimulus processing. Here we report 2 studies using a modified negative patterning discrimination to test the relationship between global processing and generalization. Global processing was associated with stronger negative patterning discrimination, indicative of limited generalization between distinct stimulus compounds and their constituent elements. In Experiment 2, participants pretrained to adopt global processing similarly showed strong negative patterning discrimination. These results demonstrate considerable individual difference in capacity to engage in negative patterning discrimination and suggest that the tendency toward global processing may be one factor explaining this variability. The need for models of learning to account for this variability in learning is discussed. PMID:24446699
Lessons Learned From Option B+ in the Evolution Toward "Test and Start" From Malawi, Cameroon, and the United Republic of Tanzania.

PubMed

Kalua, Thokozani; Tippett Barr, Beth A; van Oosterhout, Joep J; Mbori-Ngacha, Dorothy; Schouten, Erik J; Gupta, Sundeep; Sande, Amakobe; Zomba, Gerald; Tweya, Hannock; Lungu, Edgar; Kajoka, Deborah; Tih, Pius; Jahn, Andreas

2017-05-01

The acceleration of prevention of mother-to-child transmission (PMTCT) activities, coupled with the rollout of 2010 World Health Organization (WHO) guidelines, led to important discussions and innovations at global and country levels. One paradigm-shifting innovation was Option B+ in Malawi. It was later included in WHO guidelines and eventually adopted by all 22 Global Plan priority countries. This article presents Malawi's experience with designing and implementing Option B+ and provides complementary narratives from Cameroon and Tanzania. Malawi's HIV program started in 2002, but by 2009, the PMTCT program was lagging far behind the antiretroviral therapy (ART) program because of numerous health system challenges. When WHO recommended Option A and Option B for PMTCT in 2010, it was clear that Malawi's HIV program would not be able to successfully implement either option without increasing existing barriers to PMTCT services and potentially decreasing women's access to care. Subsequent stakeholder discussions led to the development of Option B+. Operationalizing Option B+ required several critical considerations, including the complete integration of ART and PMTCT programs, systematic reduction of barriers to facilitate doubling the number of ART sites in less than a year, building consensus with stakeholders, and securing additional resources for the new program. During the planning and implementation process, several lessons were learned which are considerations for countries transitioning to "treat-all": Comprehensive change requires effective government leadership and coordination; national clinical guidelines must accommodate health system limitations; ART services and commodities should be decentralized within facilities; the general public should be well informed about major changes in the national HIV program; and patients should be educated on clinic processes to improve program monitoring.
A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings.

PubMed

Maar, Marion A; Yeates, Karen; Perkins, Nancy; Boesch, Lisa; Hua-Stewart, Diane; Liu, Peter; Sleeth, Jessica; Tobe, Sheldon W

2017-04-20

To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. Building on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension-Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. Our literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. Four human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. Using DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege). ©Marion A Maar, Karen Yeates, Nancy Perkins, Lisa Boesch, Diane Hua-Stewart, Peter Liu, Jessica Sleeth, Sheldon W Tobe. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.04.2017.
Rapid Processing of a Global Feature in the ON Visual Pathways of Behaving Monkeys.

PubMed

Huang, Jun; Yang, Yan; Zhou, Ke; Zhao, Xudong; Zhou, Quan; Zhu, Hong; Yang, Yingshan; Zhang, Chunming; Zhou, Yifeng; Zhou, Wu

2017-01-01

Visual objects are recognized by their features. Whereas, some features are based on simple components (i.e., local features, such as orientation of line segments), some features are based on the whole object (i.e., global features, such as an object having a hole in it). Over the past five decades, behavioral, physiological, anatomical, and computational studies have established a general model of vision, which starts from extracting local features in the lower visual pathways followed by a feature integration process that extracts global features in the higher visual pathways. This local-to-global model is successful in providing a unified account for a vast sets of perception experiments, but it fails to account for a set of experiments showing human visual systems' superior sensitivity to global features. Understanding the neural mechanisms underlying the "global-first" process will offer critical insights into new models of vision. The goal of the present study was to establish a non-human primate model of rapid processing of global features for elucidating the neural mechanisms underlying differential processing of global and local features. Monkeys were trained to make a saccade to a target in the black background, which was different from the distractors (white circle) in color (e.g., red circle target), local features (e.g., white square target), a global feature (e.g., white ring with a hole target) or their combinations (e.g., red square target). Contrary to the predictions of the prevailing local-to-global model, we found that (1) detecting a distinction or a change in the global feature was faster than detecting a distinction or a change in color or local features; (2) detecting a distinction in color was facilitated by a distinction in the global feature, but not in the local features; and (3) detecting the hole was interfered by the local features of the hole (e.g., white ring with a squared hole). These results suggest that monkey ON visual systems have a subsystem that is more sensitive to distinctions in the global feature than local features. They also provide the behavioral constraints for identifying the underlying neural substrates.
Adjunctive sarcosine plus benzoate improved cognitive function in chronic schizophrenia patients with constant clinical symptoms: A randomised, double-blind, placebo-controlled trial.

PubMed

Lin, Chun-Yuan; Liang, Sun-Yuan; Chang, Yue-Cune; Ting, Shuo-Yen; Kao, Ching-Ling; Wu, Yu-Hsin; Tsai, Guochuan E; Lane, Hsien-Yuan

2017-08-01

Objectives Hypofunction of NMDA receptor is implicated in the pathophysiology, particularly cognitive impairment, of schizophrenia. Sarcosine, a glycine transporter I (GlyT-1) inhibitor, and sodium benzoate, a d-amino acid oxidase (DAAO) inhibitor, can both enhance NMDA receptor-mediated neurotransmission. We proposed simultaneously inhibiting DAAO and GlyT-1 may be more effective than inhibition of either in improving the cognitive and global functioning of schizophrenia patients. Methods This study compared add-on sarcosine (2 g/day) plus benzoate (1 g/day) vs. sarcosine (2 g/day) for the clinical symptoms, as well as the cognitive and global functioning, of chronic schizophrenia patients in a 12-week, double-blind, randomised, placebo-controlled trial. Participants were measured with the Positive and Negative Syndrome Scale and the Global Assessment of Functioning Scale every 3 weeks. Seven cognitive domains, recommended by the Measurement and Treatment Research to Improve Cognition in Schizophrenia Committee, were measured at weeks 0 and 12. Results Adjunctive sarcosine plus benzoate, but not sarcosine alone, improved the cognitive and global functioning of patients with schizophrenia, even when their clinical symptoms had not improved. Conclusions This finding suggests N-methyl-d-aspartate receptor-enhancement therapy can improve the cognitive function of patients with schizophrenia, further indicating this pro-cognitive effect can be primary without improvement in clinical symptoms.
Anchoring the Panic Disorder Severity Scale

ERIC Educational Resources Information Center

Keough, Meghan E.; Porter, Eliora; Kredlow, M. Alexandra; Worthington, John J.; Hoge, Elizabeth A.; Pollack, Mark H.; Shear, M. Katherine; Simon, Naomi M.

2012-01-01

The Panic Disorder Severity Scale (PDSS) is a clinician-administered measure of panic disorder symptom severity widely used in clinical research. This investigation sought to provide clinically meaningful anchor points for the PDSS both in terms of clinical severity as measured by the Clinical Global Impression-Severity Scale (CGI-S) and to extend…
Global health and domestic policy - What motivated the development of the German Global Health Strategy?

PubMed

Aluttis, Christoph; Clemens, Timo; Krafft, Thomas

2017-09-01

In 2013, the German government published its national Global Health Strategy, outlining principles and focal topics for German engagement in global health. We asked the question of why Germany has decided to establish a national policy framework for global health at this point in time, and how the development process has taken place. The ultimate goal of this study was to achieve better insights into the respective health and foreign policy processes at the national level. This article reports on the results of semi-structured interviews with those actors that were responsible for initiating and drafting the German Global Health Strategy (GGHS). Our study shows that a series of external developments, stakeholders, and advocacy efforts created an environment conducive to the creation of the strategic document. In addition, a number of internal considerations, struggles, and capacities played a decisive role during the development phase of the GGHS. Understanding these factors better can not only provide substantial insights into global health related policy processes in Germany, but also contribute to the general discourse on the role of the nation state in global health governance.
Forest, Trees, Dynamics: Results from a Novel Wisconsin Card Sorting Test Variant Protocol for Studying Global-Local Attention and Complex Cognitive Processes

PubMed Central

Cowley, Benjamin; Lukander, Kristian

2016-01-01

Background: Recognition of objects and their context relies heavily on the integrated functioning of global and local visual processing. In a realistic setting such as work, this processing becomes a sustained activity, implying a consequent interaction with executive functions. Motivation: There have been many studies of either global-local attention or executive functions; however it is relatively novel to combine these processes to study a more ecological form of attention. We aim to explore the phenomenon of global-local processing during a task requiring sustained attention and working memory. Methods: We develop and test a novel protocol for global-local dissociation, with task structure including phases of divided (“rule search”) and selective (“rule found”) attention, based on the Wisconsin Card Sorting Task (WCST). We test it in a laboratory study with 25 participants, and report on behavior measures (physiological data was also gathered, but not reported here). We develop novel stimuli with more naturalistic levels of information and noise, based primarily on face photographs, with consequently more ecological validity. Results: We report behavioral results indicating that sustained difficulty when participants test their hypotheses impacts matching-task performance, and diminishes the global precedence effect. Results also show a dissociation between subjectively experienced difficulty and objective dimension of performance, and establish the internal validity of the protocol. Contribution: We contribute an advance in the state of the art for testing global-local attention processes in concert with complex cognition. With three results we establish a connection between global-local dissociation and aspects of complex cognition. Our protocol also improves ecological validity and opens options for testing additional interactions in future work. PMID:26941689
The Fallacy of the Longevity Elixir: Negligible Senescence May be Achieved, but Not by Using Something Physical.

PubMed

Kyriazis, Marios; Apostolides, Andreas

2015-01-01

The process of aging is a continuum of degeneration which eventually leads to loss of function and clinically manifest disease. Yet, in the purely therapeutic sense, there is a distinct clinical and practical separation between age-related degenerative diseases and the background process of aging itself. It is quite possible that biomedical technologies will prove invaluable in treating or alleviating the impact of distinct age-related degenerative diseases such as cardiovascular disease, arthritis or dementia. However, when it comes to addressing the fundamental, background stochastic nature of aging, it is unlikely that regenerative biotechnologies will have any appreciable impact in continually counteracting the process. In this paper we discuss some essential conceptual obstacles, both functional and translational, which will prove overwhelming and which preclude the notion that aging can be eliminated by using physical therapies. Our reasoning is two-fold: 1. Disruptive regenerative biotechnologies interfere with the complex, dynamic topological architecture of the human organism, in a manner that will render them unsuitable for clinical use against all age-related degeneration. 2. Even if some regenerative biotechnological treatments are developed in the laboratory, the translational issues will be insurmountable, and the treatments will thus be practically unusable by the general public at large. Predictions about the near or mid-term development of rejuvenating biotechnologies are not sufficiently grounded, and do not provide a framework for effective practical achievement of negligible senescence. Instead, the answer must lie in more global and abstract methods which align well with evolutionary mechanisms based on techno-cultural societal necessities. These are likely to operate in a way which ultimately may downgrade the importance of human aging and make it an evolutionarily unnecessary process.

Innovative Technics of Managing Engineers’ Global Competencies

NASA Astrophysics Data System (ADS)

Khoreshok, A. A.; Zhironkin, S. A.; Tyulenev, M. A.; Barysheva, G. A.; Blumenstein, V. Yu; Hellmer, M. C.; Potyagailov, S. V.

2016-08-01

Higher education modernization in the CIS countries takes place under the conditions of dynamic changes in economy and society. These changes are determined by the social and economic development of the country and the world globalization processes - cross-border intercultural communication, knowledge transparency, and the establishment of information society. Educational globalization is a continuous process of creating a unified global educational system, in which the distinctions between its member educational systems are being blended.
Space sensors for global change

DOE Office of Scientific and Technical Information (OSTI.GOV)

Canavan, G.H.

1994-02-15

Satellite measurements should contribute to a fuller understanding of the physical processes behind the radiation budget, exchange processes, and global change. Climate engineering requires global observation for early indications of predicted effects, which puts a premium on affordable, distributed constellations of satellites with effective, affordable sensors. Defense has a requirement for continuous global surveillance for warning of aggression, which could evolve from advanced sensors and satellites in development. Many climate engineering needs match those of defense technologies.
Transferring Exome Sequencing Data from Clinical Laboratories to Healthcare Providers: Lessons Learned at a Pediatric Hospital

PubMed Central

Swaminathan, Rajeswari; Huang, Yungui; Miller, Katherine; Pastore, Matthew; Hashimoto, Sayaka; Jacobson, Theodora; Mouhlas, Danielle; Lin, Simon

2018-01-01

The adoption rate of genome sequencing for clinical diagnostics has been steadily increasing leading to the possibility of improvement in diagnostic yields. Although laboratories generate a summary clinical report, sharing raw genomic data with healthcare providers is equally important, both for secondary research studies as well as for a deeper analysis of the data itself, as seen by the efforts from organizations such as American College of Medical Genetics and Genomics and Global Alliance for Genomics and Health. Here, we aim to describe the existing protocol of genomic data sharing between a certified clinical laboratory and a healthcare provider and highlight some of the lessons learned. This study tracked and subsequently evaluated the data transfer workflow for 19 patients, all of whom consented to be part of this research study and visited the genetics clinic at a tertiary pediatric hospital between April 2016 to December 2016. Two of the most noticeable elements observed through this study are the manual validation steps and the discrepancies in patient identifiers used by a clinical lab vs. healthcare provider. Both of these add complexity to the transfer process as well as make it more susceptible to errors. The results from this study highlight some of the critical changes that need to be made in order to improve genomic data sharing workflows between healthcare providers and clinical sequencing laboratories. PMID:29515625
Surgeons' and Trauma Care Physicians' Perception of the Impact of the Globalization of Medical Education on Quality of Care in Lima, Peru.

PubMed

LaGrone, Lacey N; Isquith-Dicker, Leah N; Huaman Egoavil, Eduardo; Rodriguez Castro, Manuel J A; Allagual, Alfredo; Revoredo, Fernando; Mock, Charles N

2017-03-01

The globalization of medical education-the process by which trainees in any region gain access to international training (electronic or in-person)-is a growing trend. More data are needed to inform next steps in the responsible stewardship of this process, from the perspective of trainees and institutions at all income levels, and for use by national and international policymakers. To describe the impact of the globalization of medical education on surgical care in Peru from the perspective of Peruvian surgeons who received international training. Observational study of qualitative interviews conducted from September 2015 to January 2016 using grounded theory qualitative research methods. The study was conducted at 10 large public institutions that provide most of the trauma care in Lima, Peru, and included urban resident and faculty surgery and trauma care physicians. Access to international surgical rotations and medical information. Outcome measures defining the impact of globalization on surgical care were developed as part of simultaneous data collection and analysis during qualitative research as part of a larger project on trauma quality improvement practices in Peru. Fifty qualitative interviews of surgeons and emergency medicine physicians were conducted at 10 hospitals, including multiple from the public and social security systems. A median of 4 interviews were conducted at each hospital, and fewer than 3 interviews were conducted at only 1 hospital. From the broader theme of globalization emerged subthemes of an eroded sense of agency and a perception of inadequate training on the adaptation of international standards as negative effects of globalization on surgical care in Peru. Access to research funds, provision of incentives for acquisition of advanced clinical training, increased expectations for patient outcomes, and education in quality improvement skills are ways in which globalization positively affected surgeons and their patients in Peru. Short-term overseas training of surgeons from low- and middle-income countries may improve care in the surgeons' country of origin through the acquisition of skills and altered expectations for excellence. Prioritization of evidence-based medical education is necessary given widespread internet access and thus clinician exposure to variable quality medical information. Finally, the establishment of centers of excellence in low- and middle-income countries may address the eroded sense of agency attributable to globalization and offer a local example of world-class surgical outcomes, diminishing surgeons' most frequently cited reason for emigration: access to better surgical training.
Global clinical response in Cushing’s syndrome patients treated with mifepristone

PubMed Central

Katznelson, Laurence; Loriaux, D Lynn; Feldman, David; Braunstein, Glenn D; Schteingart, David E; Gross, Coleman

2014-01-01

Objective Mifepristone, a glucocorticoid receptor antagonist, improves clinical status in patients with Cushing’s syndrome (CS). We examined the pattern, reliability and correlates of global clinical response (GCR) assessments during a 6-month clinical trial of mifepristone in CS. Design Post hoc analysis of secondary end-point data from a 24-week multicentre, open-label trial of mifepristone (300–1200mg daily) in CS. Intraclass correlation coefficient (ICC) was used to examine rater concordance, and drivers of clinical improvement were determined by multivariate regression analysis. Patients Forty-six adult patients with refractory CS along with diabetes mellitus type 2 or impaired glucose tolerance, and/or a diagnosis of hypertension. Measurements Global clinical assessment made by three independent reviewers using a three-point ordinal scale (+1 = improvement; 0=no change; −1=worsening) based on eight broad clinical categories including glucose control, lipids, blood pressure, body composition, clinical appearance, strength, psychiatric/cognitive symptoms and quality of life at Weeks 6, 10, 16, and 24. Results Positive GCR increased progressively over time with 88% of patients having improved at Week 24 (P<0·001). The full concordance among reviewers occurred in 76·6% of evaluations resulting in an ICC of 0·652 (P<0·001). Changes in body weight (P<0·0001), diastolic blood pressure (P<0·0001), two-hour postoral glucose challenge glucose concentration (P = 0·0003), and Cushingoid appearance (P=0·022) were strong correlates of GCR. Conclusions Mifepristone treatment for CS results in progressive clinical improvement. Overall agreement among clinical reviewers was substantial and determinants of positive GCR included change in weight, blood pressure, glucose levels and appearance. PMID:24102404
Can Quantum Physics Find the Answer to the World Financial Crisis.

NASA Astrophysics Data System (ADS)

Dieng, Lamine

2014-03-01

We assume the global wealth of nations within the G-Global to be an American call option described as a stochastic process. We let the American call option to grow and to eventually generate profits to the nations of the G-Global. We show profits taken to be a discontinuous process, because when an investment banker or a country makes more profits continuously, then their vision will be guided by greed. When banks try to maximize profits continuously and so they operate on the edge of bankruptcy. We also assume the global wealth to be an index defined in terms of the expected global wealth of nations and normalized by their GDPs. We impose the following conditions: a). The sum of the GDPs of all nations making the G-Global is one (1), the normalizing GDP should not have an influence on the global wealth. All nations should be treated on the same footing. b). the change of the global wealth of nations to be a supermartingale. We set the drift term of the expectation decreasing process to be equal to zero. We obtain an Ordinary Differential Equation describing the dynamic of global wealth
Multidatabase Query Processing with Uncertainty in Global Keys and Attribute Values.

ERIC Educational Resources Information Center

Scheuermann, Peter; Li, Wen-Syan; Clifton, Chris

1998-01-01

Presents an approach for dynamic database integration and query processing in the absence of information about attribute correspondences and global IDs. Defines different types of equivalence conditions for the construction of global IDs. Proposes a strategy based on ranked role-sets that makes use of an automated semantic integration procedure…
Information Technologies and Globalization: New Perspectives of Teaching Learning Process

ERIC Educational Resources Information Center

Hussain, Irshad

2008-01-01

This article discusses how information technologies and globalization have opened new avenues and horizons for educators and learners. It discusses different experiences of using information and communication technologies (ICTs) in teaching learning process the world over in the age of globalization. It focuses on the ways these new trends have…
Global sensitivity analysis of DRAINMOD-FOREST, an integrated forest ecosystem model

Treesearch

Shiying Tian; Mohamed A. Youssef; Devendra M. Amatya; Eric D. Vance

2014-01-01

Global sensitivity analysis is a useful tool to understand process-based ecosystem models by identifying key parameters and processes controlling model predictions. This study reported a comprehensive global sensitivity analysis for DRAINMOD-FOREST, an integrated model for simulating water, carbon (C), and nitrogen (N) cycles and plant growth in lowland forests. The...
Making Education Markets through Global Trade Agreements

ERIC Educational Resources Information Center

Robertson, Susan L.

2017-01-01

This paper uses the global trade negotiations and agreements, which include education sectors as potentially tradable services, to show the complex processes at work in making global education markets. Drawing on the work of Jens Beckert and others, I focus on the micro-processes of making capitalist orders and the challenges at hand in bringing…
Kyoto global consensus report on Helicobacter pylori gastritis

PubMed Central

Sugano, Kentaro; Tack, Jan; Kuipers, Ernst J; Graham, David Y; El-Omar, Emad M; Miura, Soichiro; Haruma, Ken; Asaka, Masahiro; Uemura, Naomi; Malfertheiner, Peter

2015-01-01

Objective To present results of the Kyoto Global Consensus Meeting, which was convened to develop global consensus on (1) classification of chronic gastritis and duodenitis, (2) clinical distinction of dyspepsia caused by Helicobacter pylori from functional dyspepsia, (3) appropriate diagnostic assessment of gastritis and (4) when, whom and how to treat H. pylori gastritis. Design Twenty-three clinical questions addressing the above-mentioned four domains were drafted for which expert panels were asked to formulate relevant statements. A Delphi method using an anonymous electronic system was adopted to develop the consensus, the level of which was predefined as ≥80%. Final modifications of clinical questions and consensus were achieved at the face-to-face meeting in Kyoto. Results All 24 statements for 22 clinical questions after extensive modifications and omission of one clinical question were achieved with a consensus level of >80%. To better organise classification of gastritis and duodenitis based on aetiology, a new classification of gastritis and duodenitis is recommended for the 11th international classification. A new category of H. pylori-associated dyspepsia together with a diagnostic algorithm was proposed. The adoption of grading systems for gastric cancer risk stratification, and modern image-enhancing endoscopy for the diagnosis of gastritis, were recommended. Treatment to eradicate H. pylori infection before preneoplastic changes develop, if feasible, was recommended to minimise the risk of more serious complications of the infection. Conclusions A global consensus for gastritis was developed for the first time, which will be the basis for an international classification system and for further research on the subject. PMID:26187502
[Non-rigid medical image registration based on mutual information and thin-plate spline].

PubMed

Cao, Guo-gang; Luo, Li-min

2009-01-01

To get precise and complete details, the contrast in different images is needed in medical diagnosis and computer assisted treatment. The image registration is the basis of contrast, but the regular rigid registration does not satisfy the clinic requirements. A non-rigid medical image registration method based on mutual information and thin-plate spline was present. Firstly, registering two images globally based on mutual information; secondly, dividing reference image and global-registered image into blocks and registering them; then getting the thin-plate spline transformation according to the shift of blocks' center; finally, applying the transformation to the global-registered image. The results show that the method is more precise than the global rigid registration based on mutual information and it reduces the complexity of getting control points and satisfy the clinic requirements better by getting control points of the thin-plate transformation automatically.
The ethics and safety of medical student global health electives

PubMed Central

Dell, Evelyn M.; Varpio, Lara; Petrosoniak, Andrew; Gajaria, Amy

2014-01-01

Objectives To explore and characterize the ethical and safety challenges of global health experiences as they affect medical students in order to better prepare trainees to face them. Methods Semi-structured interviews were conducted with 23 Canadian medical trainees who had participated in global health experiences during medical school. Convenience and snowball sampling were utilized. Using Moustakas’s transcendental phenomenological approach, participant descriptions of ethical dilemmas and patient/trainee safety problems were analyzed. This generated an aggregate that illustrates the essential meanings of global health experience ethical and safety issues faced. Results We interviewed 23 participants who had completed 38 electives (71%, n=27, during pre-clinical years) spend-ing a mean 6.9 weeks abroad, and having visited 23 countries. Sixty percent (n=23) had pre-departure training while 36% (n=14) had post-experience debriefing. Three macro-level themes were identified: resource disparities and provision of care; navigating clinical ethical dilemmas; and threats to trainee safety. Conclusions Medical schools have a responsibility to ensure ethical and safe global health experiences. However, our findings suggest that medical students are often poorly prepared for the ethical and safety dilemmas they encounter during these electives. Medical students require intensive pre-departure training that will prepare them emotionally to deal with these dilemmas. Such training should include discussions of how to comply with clinical limitations. PMID:25341214
Hemispheric specialization for global and local processing: A direct comparison of linguistic and non-linguistic stimuli.

PubMed

Brederoo, Sanne G; Nieuwenstein, Mark R; Lorist, Monicque M; Cornelissen, Frans W

2017-12-01

It is often assumed that the human brain processes the global and local properties of visual stimuli in a lateralized fashion, with a left hemisphere (LH) specialization for local detail, and a right hemisphere (RH) specialization for global form. However, the evidence for such global-local lateralization stems predominantly from studies using linguistic stimuli, the processing of which has shown to be LH lateralized in itself. In addition, some studies have reported a reversal of global-local lateralization when using non-linguistic stimuli. Accordingly, it remains unclear whether global-local lateralization may in fact be stimulus-specific. To address this issue, we asked participants to respond to linguistic and non-linguistic stimuli that were presented in the right and left visual fields, allowing for first access by the LH and RH, respectively. The results showed global-RH and local-LH advantages for both stimulus types, but the global lateralization effect was larger for linguistic stimuli. Furthermore, this pattern of results was found to be robust, as it was observed regardless of two other task manipulations. We conclude that the instantiation and direction of global and local lateralization is not stimulus-specific. However, the magnitude of global,-but not local-, lateralization is dependent on stimulus type. Copyright © 2017 Elsevier Inc. All rights reserved.
Influence of embryo culture medium on incidence of ectopic pregnancy in in vitro fertilization.

PubMed

Lin, Shengli; Li, Rong; Zheng, Xiaoying; Chi, Hongbin; Ren, Xiulian; Yang, Rui; Liu, Ping; Qiao, Jie

2015-12-01

To explore the effect of type of media used to culture embryos for IVF on the incidence of ectopic pregnancy (EP). Retrospective analysis. University-affiliated IVF center. The retrospective analysis involved 23,481 women who underwent IVF-ET cycles between 2011 and 2013. None. There was an association between EP and the culture medium. During 23,481 fresh transfer cycles, 364 patients were diagnosed with EP. The EP to clinical pregnancy rate was 3.01% in the G5 group, 3.89% in the G5 Plus group, and 4.04% in the Global group. The EP to clinical pregnancy rates were significantly higher in the G5 Plus and Global groups than in the G5 group. After adjusting for confounding factors, the incidence of EP was significantly associated with the G5 Plus and Global media. Our results showed that there is an association between incidence of EP and the culture medium. The rates of EP to clinical pregnancy were significantly higher in the G5 Plus and Global media than in the G5 medium. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
Global and local processing near the left and right hands

PubMed Central

Langerak, Robin M.; La Mantia, Carina L.; Brown, Liana E.

2013-01-01

Visual targets can be processed more quickly and reliably when a hand is placed near the target. Both unimodal and bimodal representations of hands are largely lateralized to the contralateral hemisphere, and since each hemisphere demonstrates specialized cognitive processing, it is possible that targets appearing near the left hand may be processed differently than targets appearing near the right hand. The purpose of this study was to determine whether visual processing near the left and right hands interacts with hemispheric specialization. We presented hierarchical-letter stimuli (e.g., small characters used as local elements to compose large characters at the global level) near the left or right hands separately and instructed participants to discriminate the presence of target letters (X and O) from non-target letters (T and U) at either the global or local levels as quickly as possible. Targets appeared at either the global or local level of the display, at both levels, or were absent from the display; participants made foot-press responses. When discriminating target presence at the global level, participants responded more quickly to stimuli presented near the left hand than near either the right hand or in the no-hand condition. Hand presence did not influence target discrimination at the local level. Our interpretation is that left-hand presence may help participants discriminate global information, a right hemisphere (RH) process, and that the left hand may influence visual processing in a way that is distinct from the right hand. PMID:24194725
Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

PubMed

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time. We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials. 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%). Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are international. The latter appeared to be conducted in preferentially selected countries.
Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials

PubMed Central

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Background Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry–sponsored clinical trials and its evolution over time. Methods We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry–sponsored international trials. Results 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry–sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry–sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry–sponsored trials (from 42.4% to 37.2%). Conclusions Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry–sponsored clinical research. Only 3% of academic trials but 30% of industry trials are international. The latter appeared to be conducted in preferentially selected countries. PMID:26658791
Contributions of change in clinical status parameters to Patient Global Impression of Change (PGIC) scores among persons with fibromyalgia treated with milnacipran.

PubMed

Geisser, Michael E; Clauw, Daniel J; Strand, Vibeke; Gendreau, R Michael; Palmer, Robert; Williams, David A

2010-05-01

Clinical trials on the treatment of pain syndromes have adopted Patient Global Impression of Change (PGIC) as a primary outcome. However, little is known about how change in clinical status influences these ratings. The present study examined relationships between changes in pain, depressed mood, physical functioning, vitality, sleep disturbance, cognitive complaints, and PGIC ratings among 1260 participants with fibromyalgia (FM) who completed one of two trials examining the safety and efficacy of milnacipran. Many of the relationships between change in clinical status and PGIC ratings were stronger among persons who rated themselves as improved (responders) versus those reporting no change or a worsening of their condition (non-responders). Among non-responders, simultaneous regression analysis revealed that greater degrees of depressed mood and pain, and poorer physical function were significantly associated with worse PGIC ratings. Among responders, improvements in pain were significantly associated with better PGIC ratings, along with improvements in vitality, sleep, physical function, and cognitive complaints. These findings underscore the complexity of global ratings in FM patients, and suggest the association between clinical status and PGIC ratings varies as a function of perceived treatment response. Several domains were associated with PGIC ratings, highlighting the need to assess multiple outcomes in clinical trials of treatments for FM. Copyright 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
Modeling and Analysis of Global and Regional Climate Change in Relation to Atmospheric Hydrologic Processes

NASA Technical Reports Server (NTRS)

Johnson, Donald R.

2001-01-01

This research was directed to the development and application of global isentropic modeling and analysis capabilities to describe hydrologic processes and energy exchange in the climate system, and discern regional climate change. An additional objective was to investigate the accuracy and theoretical limits of global climate predictability which are imposed by the inherent limitations of simulating trace constituent transport and the hydrologic processes of condensation, precipitation and cloud life cycles.

Non-communicable diseases and global health governance: enhancing global processes to improve health development

PubMed Central

Magnusson, Roger S

2007-01-01

This paper assesses progress in the development of a global framework for responding to non-communicable diseases, as reflected in the policies and initiatives of the World Health Organization (WHO), World Bank and the UN: the institutions most capable of shaping a coherent global policy. Responding to the global burden of chronic disease requires a strategic assessment of the global processes that are likely to be most effective in generating commitment to policy change at country level, and in influencing industry behaviour. WHO has adopted a legal process with tobacco (the WHO Framework Convention on Tobacco Control), but a non-legal, advocacy-based approach with diet and physical activity (the Global Strategy on Diet, Physical Activity and Health). The paper assesses the merits of the Millennium Development Goals (MDGs) and the FCTC as distinct global processes for advancing health development, before considering what lessons might be learned for enhancing the implementation of the Global Strategy on Diet. While global partnerships, economic incentives, and international legal instruments could each contribute to a more effective global response to chronic diseases, the paper makes a special case for the development of international legal standards in select areas of diet and nutrition, as a strategy for ensuring that the health of future generations does not become dependent on corporate charity and voluntary commitments. A broader frame of reference for lifestyle-related chronic diseases is needed: one that draws together WHO's work in tobacco, nutrition and physical activity, and that envisages selective use of international legal obligations, non-binding recommendations, advocacy and policy advice as tools of choice for promoting different elements of the strategy. PMID:17519005
Non-communicable diseases and global health governance: enhancing global processes to improve health development.

PubMed

Magnusson, Roger S

2007-05-22

This paper assesses progress in the development of a global framework for responding to non-communicable diseases, as reflected in the policies and initiatives of the World Health Organization (WHO), World Bank and the UN: the institutions most capable of shaping a coherent global policy. Responding to the global burden of chronic disease requires a strategic assessment of the global processes that are likely to be most effective in generating commitment to policy change at country level, and in influencing industry behaviour. WHO has adopted a legal process with tobacco (the WHO Framework Convention on Tobacco Control), but a non-legal, advocacy-based approach with diet and physical activity (the Global Strategy on Diet, Physical Activity and Health). The paper assesses the merits of the Millennium Development Goals (MDGs) and the FCTC as distinct global processes for advancing health development, before considering what lessons might be learned for enhancing the implementation of the Global Strategy on Diet. While global partnerships, economic incentives, and international legal instruments could each contribute to a more effective global response to chronic diseases, the paper makes a special case for the development of international legal standards in select areas of diet and nutrition, as a strategy for ensuring that the health of future generations does not become dependent on corporate charity and voluntary commitments. A broader frame of reference for lifestyle-related chronic diseases is needed: one that draws together WHO's work in tobacco, nutrition and physical activity, and that envisages selective use of international legal obligations, non-binding recommendations, advocacy and policy advice as tools of choice for promoting different elements of the strategy.
Information processing speed as a mediator between psychosocial stress and global cognition in older adults.

PubMed

Foong, Hui F; Hamid, Tengku A; Ibrahim, Rahimah; Haron, Sharifah A

2018-01-01

The link between psychosocial stress and cognitive function is complex, and previous studies have indicated that it may be mediated by processing speed. Therefore, the main aim of this study was to examine whether processing speed mediates the association between psychosocial stress and global cognition in older adults. Moreover, the moderating role of gender in this model is examined as well. The study included 2322 community-dwelling older adults in Malaysia who were randomly selected through a multistage proportional cluster random sampling technique. Global cognition construct was measured by the Mini-Mental State Examination and Montreal Cognitive Assessment; psychosocial stress construct was measured by perceived stress, depression, loneliness, and neuroticism; and processing speed was assessed by the Digit Symbol Substitution Test. Structural equation modelling was used to analyze the mediation and moderation tests. Processing speed was found to partially mediate the relationship between psychosocial stress and global cognition (β in the direct model = -0.15, P < 0.001; β in the full mediation model = -0.11, P < 0.001). Moreover, the relationship between psychosocial stress and global cognition was found to be significant in men only, whereas the association between processing speed and global cognition was significant in men and women. Psychosocial stress may increase the likelihood that older adults will experience poor processing capacity, which could reduce their higher level cognition. Results indicate that there is a need to develop processing capacity intervention programmes for psychologically distressed older adults to prevent them from suffering cognitive decline. © 2018 Japanese Psychogeriatric Society.
The clinical concept of fibromyalgia as a changing paradigm in the past 20 years.

PubMed

Fitzcharles, Mary-Ann; Yunus, Muhammad B

2012-01-01

Fibromyalgia (FMS) is a valid clinical condition that affects 2%-4% of the population with a pivot symptom of widespread body pain. The cause and cure of FMS are as yet unknown. The concept of FMS has evolved over the past two decades to incorporate symptoms beyond pain as contributing to the global spectrum of suffering. FMS is now recognized to be grounded in the neurological domain with evidence of dysregulation of pain processing. Appreciation of the neurophysiologic mechanisms operative in FMS has contributed to rational treatment recommendations, although a "gold standard treatment" does not currently exist. Ideal treatments for FMS patients should be individualized with emphasis on active patient participation, good health practices, and multimodal intervention, incorporating nonpharmacologic and pharmacologic treatments. Predictors of outcome, which is favourable in over 50% of patients, are unknown, but those with better outcome do more physical activity and use fewer medications.
Recommendations for the standardization and interpretation of the electrocardiogram: part I: the electrocardiogram and its technology a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society endorsed by the International Society for Computerized Electrocardiology.

PubMed

Kligfield, Paul; Gettes, Leonard S; Bailey, James J; Childers, Rory; Deal, Barbara J; Hancock, E William; van Herpen, Gerard; Kors, Jan A; Macfarlane, Peter; Mirvis, David M; Pahlm, Olle; Rautaharju, Pentti; Wagner, Galen S; Josephson, Mark; Mason, Jay W; Okin, Peter; Surawicz, Borys; Wellens, Hein

2007-03-13

This statement examines the relation of the resting ECG to its technology. Its purpose is to foster understanding of how the modern ECG is derived and displayed and to establish standards that will improve the accuracy and usefulness of the ECG in practice. Derivation of representative waveforms and measurements based on global intervals are described. Special emphasis is placed on digital signal acquisition and computer-based signal processing, which provide automated measurements that lead to computer-generated diagnostic statements. Lead placement, recording methods, and waveform presentation are reviewed. Throughout the statement, recommendations for ECG standards are placed in context of the clinical implications of evolving ECG technology.
Recommendations for the standardization and interpretation of the electrocardiogram: part I: The electrocardiogram and its technology: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society: endorsed by the International Society for Computerized Electrocardiology.

PubMed

Kligfield, Paul; Gettes, Leonard S; Bailey, James J; Childers, Rory; Deal, Barbara J; Hancock, E William; van Herpen, Gerard; Kors, Jan A; Macfarlane, Peter; Mirvis, David M; Pahlm, Olle; Rautaharju, Pentti; Wagner, Galen S; Josephson, Mark; Mason, Jay W; Okin, Peter; Surawicz, Borys; Wellens, Hein

2007-03-13

This statement examines the relation of the resting ECG to its technology. Its purpose is to foster understanding of how the modern ECG is derived and displayed and to establish standards that will improve the accuracy and usefulness of the ECG in practice. Derivation of representative waveforms and measurements based on global intervals are described. Special emphasis is placed on digital signal acquisition and computer-based signal processing, which provide automated measurements that lead to computer-generated diagnostic statements. Lead placement, recording methods, and waveform presentation are reviewed. Throughout the statement, recommendations for ECG standards are placed in context of the clinical implications of evolving ECG technology.
Speech and pause characteristics in multiple sclerosis: A preliminary study of speakers with high and low neuropsychological test performance

PubMed Central

FEENAUGHTY, LYNDA; TJADEN, KRIS; BENEDICT, RALPH H.B.; WEINSTOCK-GUTTMAN, BIANCA

2017-01-01

This preliminary study investigated how cognitive-linguistic status in multiple sclerosis (MS) is reflected in two speech tasks (i.e. oral reading, narrative) that differ in cognitive-linguistic demand. Twenty individuals with MS were selected to comprise High and Low performance groups based on clinical tests of executive function and information processing speed and efficiency. Ten healthy controls were included for comparison. Speech samples were audio-recorded and measures of global speech timing were obtained. Results indicated predicted differences in global speech timing (i.e. speech rate and pause characteristics) for speech tasks differing in cognitive-linguistic demand, but the magnitude of these task-related differences was similar for all speaker groups. Findings suggest that assumptions concerning the cognitive-linguistic demands of reading aloud as compared to spontaneous speech may need to be re-considered for individuals with cognitive impairment. Qualitative trends suggest that additional studies investigating the association between cognitive-linguistic and speech motor variables in MS are warranted. PMID:23294227
The ABCs of the US Broad Spectrum Antimicrobials Program: Antibiotics, Biosecurity, and Congress

PubMed Central

2015-01-01

Antibiotic resistance has been increasing at an alarming rate in the United States and globally for decades, but the problem has only recently gained broad attention at the highest levels of the US government. More and more patients are dying of infections that do not respond to antibiotics that are currently available. Meanwhile, the antibacterial product pipeline remains fragile in part because of a lack of commercial interest from pharmaceutical companies. The Biomedical Advanced Research and Development Authority (BARDA) Broad Spectrum Antimicrobials (BSA) program leads the US government's effort to bridge this gap by advancing new antibacterials through late stages of clinical development. Other commentators have described in detail BARDA's structure, process, and role in antibacterial development. This commentary offers a public policy perspective on the emerging politics of antibiotic resistance in the context of US biosecurity politics and medical countermeasure (MCM) development. It identifies promising developments and difficult challenges that together will ultimately determine whether BARDA can become a global leader for antibiotic development. PMID:26569379
Brain training game improves executive functions and processing speed in the elderly: a randomized controlled trial.

PubMed

Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Hashizume, Hiroshi; Akitsuki, Yuko; Shigemune, Yayoi; Sekiguchi, Atsushi; Kotozaki, Yuka; Tsukiura, Takashi; Yomogida, Yukihito; Kawashima, Ryuta

2012-01-01

The beneficial effects of brain training games are expected to transfer to other cognitive functions, but these beneficial effects are poorly understood. Here we investigate the impact of the brain training game (Brain Age) on cognitive functions in the elderly. Thirty-two elderly volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris). This study was completed by 14 of the 16 members in the Brain Age group and 14 of the 16 members in the Tetris group. To maximize the benefit of the interventions, all participants were non-gamers who reported playing less than one hour of video games per week over the past 2 years. Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Each group played for a total of about 20 days. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into four categories (global cognitive status, executive functions, attention, and processing speed). Results showed that the effects of the brain training game were transferred to executive functions and to processing speed. However, the brain training game showed no transfer effect on any global cognitive status nor attention. Our results showed that playing Brain Age for 4 weeks could lead to improve cognitive functions (executive functions and processing speed) in the elderly. This result indicated that there is a possibility which the elderly could improve executive functions and processing speed in short term training. The results need replication in large samples. Long-term effects and relevance for every-day functioning remain uncertain as yet. UMIN Clinical Trial Registry 000002825.
Improved global simulation of groundwater-ecosystem interactions via tight coupling of a dynamic global ecosystem model and a global hydrological model

NASA Astrophysics Data System (ADS)

Braakhekke, Maarten; Rebel, Karin; Dekker, Stefan; Smith, Benjamin; Sutanudjaja, Edwin; van Beek, Rens; van Kampenhout, Leo; Wassen, Martin

2017-04-01

In up to 30% of the global land surface ecosystems are potentially influenced by the presence of a shallow groundwater table. In these regions upward water flux by capillary rise increases soil moisture availability in the root zone, which has a strong effect on evapotranspiration, vegetation dynamics, and fluxes of carbon and nitrogen. Most global hydrological models and several land surface models simulate groundwater table dynamics and their effects on land surface processes. However, these models typically have relatively simplistic representation of vegetation and do not consider changes in vegetation type and structure. Dynamic global vegetation models (DGVMs), describe land surface from an ecological perspective, combining detailed description of vegetation dynamics and structure, and biogeochemical processes and are thus more appropriate to simulate the ecological and biogeochemical effects of groundwater interactions. However, currently virtually all DGVMs ignore these effects, assuming that water tables are too deep to affect soil moisture in the root zone. We have implemented a tight coupling between the dynamic global ecosystem model LPJ-GUESS and the global hydrological model PCR-GLOBWB, which explicitly simulates groundwater dynamics. This coupled model allows us to explicitly account for groundwater effects on terrestrial ecosystem processes at global scale. Results of global simulations indicate that groundwater strongly influences fluxes of water, carbon and nitrogen, in many regions, adding up to a considerable effect at the global scale.
Process-based upscaling of surface-atmosphere exchange

NASA Astrophysics Data System (ADS)

Keenan, T. F.; Prentice, I. C.; Canadell, J.; Williams, C. A.; Wang, H.; Raupach, M. R.; Collatz, G. J.; Davis, T.; Stocker, B.; Evans, B. J.

2015-12-01

Empirical upscaling techniques such as machine learning and data-mining have proven invaluable tools for the global scaling of disparate observations of surface-atmosphere exchange, but are not based on a theoretical understanding of the key processes involved. This makes spatial and temporal extrapolation outside of the training domain difficult at best. There is therefore a clear need for the incorporation of knowledge of ecosystem function, in combination with the strength of data mining. Here, we present such an approach. We describe a novel diagnostic process-based model of global photosynthesis and ecosystem respiration, which is directly informed by a variety of global datasets relevant to ecosystem state and function. We use the model framework to estimate global carbon cycling both spatially and temporally, with a specific focus on the mechanisms responsible for long-term change. Our results show the importance of incorporating process knowledge into upscaling approaches, and highlight the effect of key processes on the terrestrial carbon cycle.
Association Between Global Longitudinal Strain and Cardiovascular Events in Patients With Left Bundle Branch Block Assessed Using Two-Dimensional Speckle-Tracking Echocardiography.

PubMed

Hwang, In-Chang; Cho, Goo-Yeong; Yoon, Yeonyee E; Park, Jin Joo

2018-01-01

The prognostic value of left ventricular (LV) global strain and twist in patients with left bundle branch block (LBBB) is not fully investigated. The aim of this study was to investigate the association between myocardial strain and twist and cardiovascular events in patients with LBBB, as assessed using two-dimensional speckle-tracking echocardiography. A total of 269 patients with LBBB (mean age, 69.5 ± 10.9 years; 46.8% men) were retrospectively identified. Using speckle-tracking, LV global longitudinal strain (GLS), global circumferential strain, and twist were measured. Association between LV global function and a composite of cardiovascular mortality and hospitalization for heart failure was compared with clinical risk factors, LV ejection fraction (LVEF), and other echocardiographic parameters. During a median of 27.5 months (interquartile range, 12.8-43.9 months), the composite end point occurred in 55 patients (20.4%). In univariate analyses, diabetes mellitus, chronic kidney disease, ischemic etiology of LBBB, dilated left atrium, reduced LVEF, dilated left ventricle, and impaired LV global strain (GLS > -12.2%, global circumferential strain > -11.8%, and twist < 6.5°) showed associations with the composite end point. In multivariate analyses, GLS was significantly associated with the composite end point (adjusted hazard ratio, 4.697; 95% CI, 1.344-16.413; P = .015), whereas global circumferential strain, twist, and LVEF were not. GLS showed an additive association with poor prognosis over clinical risk factors and other echocardiographic parameters, including LVEF. Patients with preserved LVEFs (≥40%) but impaired GLS (>-12.2%) had a larger number of clinical events than those with impaired LVEFs but preserved GLS. Among patients with LBBB, GLS can provide better risk stratification than LVEF or other echocardiographic parameters. Copyright © 2017 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.
[Does the Fragmented Images Test measure locally oriented visual processing in autism spectrum disorders?].

PubMed

Scheurich, Armin; Fellgiebel, Andreas; Müller, Mattias J; Poustka, Fritz; Bölte, Sven

2010-03-01

The cognitive phenotype of autism spectrum disorders (ASD) is characterized among other things by local processing (weak central coherence). It was examined whether a test that measures identification of fragmented pictures (FBT) is able to seize this preference for local processing. The FBT performance of 15 patients with ASD, 16 with depression, 16 with schizophrenia and of 16 control subjects was compared. In addition, two tests well known to be sensitive to local processing were assessed, namely the Embedded Figures Test (EFT) and the Block Design Test (BDT). ASD patients demonstrated a preference for local processing. Difficulties in global processing, or more specifically in gestalt perception (FBT), were accompanied by good performance on the EFT and BDT as expected. Controlling for age and nonverbal intelligence (ANCOVA) reduced differences to trends. However, the calculation of difference scores (i.e., subtraction of FBT from EFT performance) resulted in significant differences between ASD and control groups even after controlling for of age and intelligence. The FBT is a suitable exploratory test of local visual processing in ASD. In particular, a difference criterion can be generated (FBT vs. EFT) that discriminates between ASD and clinical as well as healthy control groups.
Real-life assessment of the validity of patient global impression of change in fibromyalgia.

PubMed

Rampakakis, Emmanouil; Ste-Marie, Peter A; Sampalis, John S; Karellis, Angeliki; Shir, Yoram; Fitzcharles, Mary-Ann

2015-01-01

Patient Global Rating of Change (GRC) scales are commonly used in routine clinical care given their ease of use, availability and short completion time. This analysis aimed at assessing the validity of Patient Global Impression of Change (PGIC), a GRC scale commonly used in fibromyalgia, in a Canadian real-life setting. 167 fibromyalgia patients with available PGIC data were recruited in 2005-2013 from a Canadian tertiary-care multidisciplinary clinic. In addition to PGIC, disease severity was assessed with: pain visual analogue scale (VAS); Patient Global Assessment (PGA); Fibromyalgia Impact Questionnaire (FIQ); Health Assessment Questionnaire (HAQ); McGill Pain Questionnaire; body map. Multivariate linear regression assessed the PGIC relationship with disease parameter improvement while adjusting for follow-up duration and baseline parameter levels. The Spearman's rank coefficient assessed parameter correlation. Higher PGIC scores were significantly (p<0.001) associated with greater improvement in pain, PGA, FIQ, HAQ and the body map. A statistically significant moderate positive correlation was observed between PGIC and FIQ improvement (r=0.423; p<0.001); correlation with all remaining disease severity measures was weak. Regression analysis confirmed a significant (p<0.001) positive association between improvement in all disease severity measures and PGIC. Baseline disease severity and follow-up duration were identified as significant independent predictors of PGIC rating. Despite that only a weak correlation was identified between PGIC and standard fibromyalgia outcomes improvement, in the absence of objective outcomes, PGIC remains a clinically relevant tool to assess perceived impact of disease management. However, our analysis suggests that outcome measures data should not be considered in isolation but, within the global clinical context.
Clinical Uncertainties, Health Service Challenges, and Ethical Complexities of HIV “Test-and-Treat”: A Systematic Review

PubMed Central

Shah, Kavita R.; Sarma, Karthik V.; Mahajan, Anish P.

2013-01-01

Despite the HIV “test-and-treat” strategy’s promise, questions about its clinical rationale, operational feasibility, and ethical appropriateness have led to vigorous debate in the global HIV community. We performed a systematic review of the literature published between January 2009 and May 2012 using PubMed, SCOPUS, Global Health, Web of Science, BIOSIS, Cochrane CENTRAL, EBSCO Africa-Wide Information, and EBSCO CINAHL Plus databases to summarize clinical uncertainties, health service challenges, and ethical complexities that may affect the test-and-treat strategy’s success. A thoughtful approach to research and implementation to address clinical and health service questions and meaningful community engagement regarding ethical complexities may bring us closer to safe, feasible, and effective test-and-treat implementation. PMID:23597344
Bioinformatics tools for the analysis of NMR metabolomics studies focused on the identification of clinically relevant biomarkers.

PubMed

Puchades-Carrasco, Leonor; Palomino-Schätzlein, Martina; Pérez-Rambla, Clara; Pineda-Lucena, Antonio

2016-05-01

Metabolomics, a systems biology approach focused on the global study of the metabolome, offers a tremendous potential in the analysis of clinical samples. Among other applications, metabolomics enables mapping of biochemical alterations involved in the pathogenesis of diseases, and offers the opportunity to noninvasively identify diagnostic, prognostic and predictive biomarkers that could translate into early therapeutic interventions. Particularly, metabolomics by Nuclear Magnetic Resonance (NMR) has the ability to simultaneously detect and structurally characterize an abundance of metabolic components, even when their identities are unknown. Analysis of the data generated using this experimental approach requires the application of statistical and bioinformatics tools for the correct interpretation of the results. This review focuses on the different steps involved in the metabolomics characterization of biofluids for clinical applications, ranging from the design of the study to the biological interpretation of the results. Particular emphasis is devoted to the specific procedures required for the processing and interpretation of NMR data with a focus on the identification of clinically relevant biomarkers. © The Author 2015. Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.
Evidence-based medicine: what has happened in the past 50 years?

PubMed

Mellis, Craig

2015-01-01

Although the phrase 'evidence-based medicine' (EBM) was used for the first time in the medical literature less than 25 years ago, the history of EBM goes back for centuries. What is remarkable is how popular and how globally accepted the EBM movement has become in such a short time. Many famous, past clinicians have played major roles in the disciplines that preceded EBM, particularly 'clinical epidemiology'. It soon became clear to the early EBM champions that 'evidence' was only part of the clinical decision-making process. Consequently, both clinical expertise and the patient's values and preferences were rapidly incorporated into the concept we now know as 'EBM'. The current need for high-quality, easily accessible 'evidence-based summaries' for busy clinicians is now apparent, as traditional EBM requires both considerable time and skill. Consequently, there is a progressive move away from the primary literature (such as randomised controlled trials) to systematic reviews and other 'evidence-based summaries'. The future of EBM will almost certainly involve widespread utilisation of 'clinical (computer)-based decision support systems'. © 2014 The Author. Journal of Paediatrics and Child Health © 2014 Paediatrics and Child Health Division (Royal Australasian College of Physicians).
Innovation Best Practices in the Medical Device Industry.

PubMed

Ray, Partha P; Amaral, Joseph F; Hinoul, Piet

2017-06-01

Advances in patient care often germinate from keen clinical insights and a needs-based approach to innovation. Although there is an important role for incremental improvements to existing solutions, transformational innovation is what truly drives real shifts in clinical outcomes and subsequently patient satisfaction, market access, and economic value. A good example of this is the evolution of the coronary stent market. The best innovation programs are focused on unmet needs rather than solutions, call for a careful articulation of the specific problems to be solved, involve a deep dive within a clinical area, and seek to prioritize research and development investments into areas where the greatest impact can be expected. To enhance its ability to pursue breakthrough innovation, Johnson and Johnson (J&J) has organized itself along priority disease areas, created the global J&J Innovation organization to pursue external technology and know-how, and continues to partner closely with clinical practitioners. The process undertaken at J&J to acquire a microwave ablation technology and enter the interventional oncology space is a recent case study of these innovation principles and organizational focus in action. Copyright © 2017 Elsevier Inc. All rights reserved.
[Clinical features and prognostic factors of meningococcal disease: a case series study in Chile during the 2012-2013 outbreak].

PubMed

Matute, Isabel; Olea, Andrea; López, Darío; Loayza, Sergio; Nájera, Manuel; González, Claudia; Poffald, Lucy; Hirmas, Macarena; Delgado, Iris; Pedroni, Elena; Alfaro, Tania; Gormaz, Ana María; Sanhueza, Gabriel; Vial, Pablo; Dabanch, Jeannette; Gallegos, Doris; Aguilera, Ximena

2015-10-01

Meningococcal disease (MD) is a major global problem because of its case fatality rate and sequels. Since 2012 cases of serogroup W have increased in Chile, with nonspecific clinical presentation, high case fatality rate and serious consequences. To characterize the evolution and outcome of MD cases between January 2012 and March 2013 in Chile. Case series considering 149 MD cases of 7 regions. A questionnaire was applied and clinical records were reviewed, including individual, agent, clinical course and healthcare process variables. The analysis allowed to obtain estimates of the OR as likelihood of dying. 51.5% was meningococcemia, the case fatality rate reached 27%, prevailing serogroup W (46.6%). Factors that increased the probability of dying: > age, belonging to indigenous people, having lived a stressful event, having diarrhea, impaired consciousness, cardiovascular symptoms, low oxygen saturation and low Glasgow coma scale score. The case fatality rate exceeded normal levels and was higher in serogroup W. Increasing in this serogroup, associated to the increased presence of nonspecific symptoms or rapid progression to septicemia, hit a health system accustomed to more classic meningococcal disease presentation, which could partly explain the observed increased fatality rate.
Clinical relevance of findings in trials of CBT for depression.

PubMed

Lepping, P; Whittington, R; Sambhi, R S; Lane, S; Poole, R; Leucht, S; Cuijpers, P; McCabe, R; Waheed, W

2017-09-01

Cognitive behavioural therapy (CBT) is beneficial in depression. Symptom scores can be translated into Clinical Global Impression (CGI) scale scores to indicate clinical relevance. We aimed to assess the clinical relevance of findings of randomised controlled trials (RCTs) of CBT in depression. We identified RCTs of CBT that used the Hamilton Rating Scale for Depression (HAMD). HAMD scores were translated into Clinical Global Impression - Change scale (CGI-I) scores to measure clinical relevance. One hundred and seventy datasets from 82 studies were included. The mean percentage HAMD change for treatment arms was 53.66%, and 29.81% for control arms, a statistically significant difference. Combined active therapies showed the biggest improvement on CGI-I score, followed by CBT alone. All active treatments had better than expected HAMD percentage reduction and CGI-I scores. CBT has a clinically relevant effect in depression, with a notional CGI-I score of 2.2, indicating a significant clinical response. The non-specific or placebo effect of being in a psychotherapy trial was a 29% reduction of HAMD. Copyright © 2017. Published by Elsevier Masson SAS.

Trends in TIMSS Responses over Time: Evidence of Global Forces in Education?

ERIC Educational Resources Information Center

Rutkowski, Leslie; Rutkowski, David

2009-01-01

In this article, the influence of global processes on international mathematics curricula as evidenced by item responses to 3 Trends in International Mathematics and Science Study (TIMSS) administrations (1995, 1999, and 2003) is considered. Based on Dale's (2000) argument, we set out to test 2 plausible impacts of global processes on education.…
Moral maps and medical imaginaries: clinical tourism at Malawi's College of Medicine.

PubMed

Wendland, Claire L

2012-01-01

At an understaffed and underresourced urban African training hospital, Malawian medical students learn to be doctors while foreign medical students, visiting Malawi as clinical tourists on short-term electives, learn about “global health.” Scientific ideas circulate fast there; clinical tourists circulate readily from outside to Malawi but not the reverse; medical technologies circulate slowly, erratically, and sometimes not at all. Medicine's uneven globalization is on full display. I extend scholarship on moral imaginations and medical imaginaries to propose that students map these wards variously as places in which—or from which—they seek a better medicine. Clinical tourists, enacting their own moral maps, also become representatives of medicine “out there”: points on the maps of others. Ethnographic data show that for Malawians, clinical tourists are colleagues, foils against whom they construct ideas about a superior and distinctly Malawian medicine and visions of possible alternative futures for themselves.
[Use of thrombelastography to guide posttraumatic hemostatic therapy: More coagulation factor concentrates and less allogenic blood transfusion?

PubMed

David, J S; Imhoff, E; Parat, S; Augey, L; Geay-Baillat, M-O; Incagnoli, P; Tazarourte, K

2016-11-01

Viscoelastic technics are used for 10 years and include the ROTEM ® and the TEG ® . These devices that exploit the viscoelastic properties of the clotting blood, allow a rapid and global analysis of the haemostatic process taking into account all the process interfering with haemostasis such as inflammation. It has been shown that the use of these technics in clinical situations such as trauma, postpartum haemorrhage, gastrointestinal bleeding or cardiac surgery may reduce the need for blood product, the cost and perhaps may improve the outcome of the patients. Thanks to a rapid identification of the underlying coagulation deficit, these technics facilitate decision-making during acute care and help to guide the treatment, particularly with coagulation factor's concentrate. Copyright © 2016 Elsevier Masson SAS. All rights reserved.
The landscape of viral proteomics and its potential to impact human health

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oxford, Kristie L.; Wendler, Jason P.; McDermott, Jason E.

2016-05-06

Translating the intimate discourse between viruses and their host cells during infection is a challenging but critical task for development of antiviral interventions and diagnostics. Viruses commandeer cellular processes at every step of their life cycle, altering expression of genes and proteins. Advances in mass spectrometry-based proteomic technologies are enhancing studies of viral pathogenesis by identifying virus-induced changes in the protein repertoire of infected cells or extracellular fluids. Interpretation of proteomics results using knowledge of cellular pathways and networks leads to identification of proteins that influence a range of infection processes, thereby focusing efforts for clinical diagnoses and therapeutics development.more » Herein we discuss applications of global proteomic studies of viral infections with the goal of providing a basis for improved studies that will benefit community-wide data integration and interpretation.« less
Electrophysiological evidence of altered visual processing in adults who experienced visual deprivation during infancy.

PubMed

Segalowitz, Sidney J; Sternin, Avital; Lewis, Terri L; Dywan, Jane; Maurer, Daphne

2017-04-01

We examined the role of early visual input in visual system development by testing adults who had been born with dense bilateral cataracts that blocked all patterned visual input during infancy until the cataractous lenses were removed surgically and the eyes fitted with compensatory contact lenses. Patients viewed checkerboards and textures to explore early processing regions (V1, V2), Glass patterns to examine global form processing (V4), and moving stimuli to explore global motion processing (V5). Patients' ERPs differed from those of controls in that (1) the V1 component was much smaller for all but the simplest stimuli and (2) extrastriate components did not differentiate amongst texture stimuli, Glass patterns, or motion stimuli. The results indicate that early visual deprivation contributes to permanent abnormalities at early and mid levels of visual processing, consistent with enduring behavioral deficits in the ability to process complex textures, global form, and global motion. © 2017 Wiley Periodicals, Inc.
Real-World Impact of Neurocognitive Deficits in Acute and Early HIV Infection

PubMed Central

Doyle, Katie L.; Morgan, Erin E.; Morris, Sheldon; Smith, Davey M.; Little, Susan; Iudicello, Jennifer E.; Blackstone, Kaitlin; Moore, David J.; Grant, Igor; Letendre, Scott L.; Woods, Steven Paul

2013-01-01

The acute and early period of HIV-1 infection (AEH) is characterized by neuroinflammatory and immunopathogenic processes that can alter the integrity of neural systems and neurocognitive functions. However, the extent to which central nervous system changes in AEH confer increased risk of real-world functioning (RWF) problems is not known. In the present study, 34 individuals with AEH and 39 seronegative comparison participants completed standardized neuromedical, psychiatric, and neurocognitive research evaluations, alongside a comprehensive assessment of RWF that included cognitive symptoms in daily life, basic and instrumental activities of daily living, clinician-rated global functioning, and employment. Results showed that AEH was associated with a significantly increased risk of dependence in RWF, which was particularly elevated among AEH persons with global neurocognitive impairment (NCI). Among those with AEH, NCI (i.e., deficits in learning and information processing speed), mood disorders (i.e., Bipolar Disorder), and substance dependence (e.g., methamphetamine dependence) were all independently predictive of RWF dependence. Findings suggest that neurocognitively impaired individuals with AEH are at notably elevated risk of clinically significant challenges in normal daily functioning. Screening for neurocognitive, mood, and substance use disorders in AEH may facilitate identification of individuals at high risk of functional dependence who may benefit from psychological and medical strategies to manage their neuropsychiatric conditions. PMID:24277439
Comparative Proteomic Analysis of Liver Steatosis and Fibrosis after Oral Hepatotoxicant Administration in Sprague-Dawley Rats.

PubMed

McDyre, B Claire; AbdulHameed, Mohamed Diwan M; Permenter, Matthew G; Dennis, William E; Baer, Christine E; Koontz, Jason M; Boyle, Molly H; Wallqvist, Anders; Lewis, John A; Ippolito, Danielle L

2018-02-01

The past decade has seen an increase in the development and clinical use of biomarkers associated with histological features of liver disease. Here, we conduct a comparative histological and global proteomics analysis to identify coregulated modules of proteins in the progression of hepatic steatosis or fibrosis. We orally administered the reference chemicals bromobenzene (BB) or 4,4'-methylenedianiline (4,4'-MDA) to male Sprague-Dawley rats for either 1 single administration or 5 consecutive daily doses. Livers were preserved for histopathology and global proteomics assessment. Analysis of liver sections confirmed a dose- and time-dependent increase in frequency and severity of histopathological features indicative of lipid accumulation after BB or fibrosis after 4,4'-MDA. BB administration resulted in a dose-dependent increase in the frequency and severity of inflammation and vacuolation. 4,4'-MDA administration resulted in a dose-dependent increase in the frequency and severity of periportal collagen accumulation and inflammation. Pathway analysis identified a time-dependent enrichment of biological processes associated with steatogenic or fibrogenic initiating events, cellular functions, and toxicological states. Differentially expressed protein modules were consistent with the observed histology, placing physiologically linked protein networks into context of the disease process. This study demonstrates the potential for protein modules to provide mechanistic links between initiating events and histopathological outcomes.
Understanding how and why health is integrated into foreign policy - a case study of health is global, a UK Government Strategy 2008-2013.

PubMed

Gagnon, Michelle L; Labonté, Ronald

2013-06-06

Over the past decade, global health issues have become more prominent in foreign policies at the national level. The process to develop state level global health strategies is arguably a form of global health diplomacy (GHD). Despite an increase in the volume of secondary research and analysis in this area, little primary research, particularly that which draws directly on the perspectives of those involved in these processes, has been conducted. This study seeks to fill this knowledge gap through an empirical case study of Health is Global: A UK Government Strategy 2008-2013. It aims to build understanding about how and why health is integrated into foreign policy and derive lessons of potential relevance to other nations interested in developing whole-of-government global health strategies. The major element of the study consisted of an in-depth investigation and analysis of the UK global health strategy. Document analysis and twenty interviews were conducted. Data was organized and described using an adapted version of Walt and Gilson's policy analysis triangle. A general inductive approach was used to identify themes in the data, which were then analysed and interpreted using Fidler's health and foreign policy conceptualizations and Kingdon's multiples streams model of the policymaking process. The primary reason that the UK decided to focus more on global health is self-interest - to protect national and international security and economic interests. Investing in global health was also seen as a way to enhance the UK's international reputation. A focus on global health to primarily benefit other nations and improve global health per se was a prevalent through weaker theme. A well organized, credible policy community played a critical role in the process and a policy entrepreneur with expertise in both international relations and health helped catalyze attention and action on global health when the time was right. Support from the Prime Minister and from the Foreign and Commonwealth Office was essential. The process to arrive at a government-wide strategy was complex and time-consuming, but also broke down silos. Significant negotiation and compromise were required from actors with widely varying perspectives on global health and conflicting priorities. As primarily an exploratory study, this research sheds significant light on the global health policymaking process at the level of the state. It provides a useful and important starting point for further hypothesis driven empirical research that focuses on the integration of health in foreign policy, how and why this happens and whether or not it makes an impact on improving global health.
Understanding how and why health is integrated into foreign policy - a case study of health is global, a UK Government Strategy 2008–2013

PubMed Central

2013-01-01

Background Over the past decade, global health issues have become more prominent in foreign policies at the national level. The process to develop state level global health strategies is arguably a form of global health diplomacy (GHD). Despite an increase in the volume of secondary research and analysis in this area, little primary research, particularly that which draws directly on the perspectives of those involved in these processes, has been conducted. This study seeks to fill this knowledge gap through an empirical case study of Health is Global: A UK Government Strategy 2008–2013. It aims to build understanding about how and why health is integrated into foreign policy and derive lessons of potential relevance to other nations interested in developing whole-of-government global health strategies. Methods The major element of the study consisted of an in-depth investigation and analysis of the UK global health strategy. Document analysis and twenty interviews were conducted. Data was organized and described using an adapted version of Walt and Gilson’s policy analysis triangle. A general inductive approach was used to identify themes in the data, which were then analysed and interpreted using Fidler’s health and foreign policy conceptualizations and Kingdon’s multiples streams model of the policymaking process. Results The primary reason that the UK decided to focus more on global health is self-interest - to protect national and international security and economic interests. Investing in global health was also seen as a way to enhance the UK’s international reputation. A focus on global health to primarily benefit other nations and improve global health per se was a prevalent through weaker theme. A well organized, credible policy community played a critical role in the process and a policy entrepreneur with expertise in both international relations and health helped catalyze attention and action on global health when the time was right. Support from the Prime Minister and from the Foreign and Commonwealth Office was essential. The process to arrive at a government-wide strategy was complex and time-consuming, but also broke down silos. Significant negotiation and compromise were required from actors with widely varying perspectives on global health and conflicting priorities. Conclusions As primarily an exploratory study, this research sheds significant light on the global health policymaking process at the level of the state. It provides a useful and important starting point for further hypothesis driven empirical research that focuses on the integration of health in foreign policy, how and why this happens and whether or not it makes an impact on improving global health. PMID:23742130
Uneven dietary development: linking the policies and processes of globalization with the nutrition transition, obesity and diet-related chronic diseases

PubMed Central

Hawkes, Corinna

2006-01-01

In a "nutrition transition", the consumption of foods high in fats and sweeteners is increasing throughout the developing world. The transition, implicated in the rapid rise of obesity and diet-related chronic diseases worldwide, is rooted in the processes of globalization. Globalization affects the nature of agri-food systems, thereby altering the quantity, type, cost and desirability of foods available for consumption. Understanding the links between globalization and the nutrition transition is therefore necessary to help policy makers develop policies, including food policies, for addressing the global burden of chronic disease. While the subject has been much discussed, tracing the specific pathways between globalization and dietary change remains a challenge. To help address this challenge, this paper explores how one of the central mechanisms of globalization, the integration of the global marketplace, is affecting the specific diet patterns. Focusing on middle-income countries, it highlights the importance of three major processes of market integration: (I) production and trade of agricultural goods; (II) foreign direct investment in food processing and retailing; and (III) global food advertising and promotion. The paper reveals how specific policies implemented to advance the globalization agenda account in part for some recent trends in the global diet. Agricultural production and trade policies have enabled more vegetable oil consumption; policies on foreign direct investment have facilitated higher consumption of highly-processed foods, as has global food marketing. These dietary outcomes also reflect the socioeconomic and cultural context in which these policies are operating. An important finding is that the dynamic, competitive forces unleashed as a result of global market integration facilitates not only convergence in consumption habits (as is commonly assumed in the "Coca-Colonization" hypothesis), but adaptation to products targeted at different niche markets. This convergence-divergence duality raises the policy concern that globalization will exacerbate uneven dietary development between rich and poor. As high-income groups in developing countries accrue the benefits of a more dynamic marketplace, lower-income groups may well experience convergence towards poor quality obseogenic diets, as observed in western countries. Global economic polices concerning agriculture, trade, investment and marketing affect what the world eats. They are therefore also global food and health policies. Health policy makers should pay greater attention to these policies in order to address some of the structural causes of obesity and diet-related chronic diseases worldwide, especially among the groups of low socioeconomic status. PMID:16569239
Providing Context for Complexity: Using Infographics and Conceptual Models to Teach Global Change Processes

NASA Astrophysics Data System (ADS)

Bean, J. R.; White, L. D.

2015-12-01

Understanding modern and historical global changes requires interdisciplinary knowledge of the physical and life sciences. The Understanding Global Change website from the UC Museum of Paleontology will use a focal infographic that unifies diverse content often taught in separate K-12 science units. This visualization tool provides scientists with a structure for presenting research within the broad context of global change, and supports educators with a framework for teaching and assessing student understanding of complex global change processes. This new approach to teaching the science of global change is currently being piloted and refined based on feedback from educators and scientists in anticipation of a 2016 website launch. Global change concepts are categorized within the infographic as causes of global change (e.g., burning of fossil fuels, volcanism), ongoing Earth system processes (e.g., ocean circulation, the greenhouse effect), and the changes scientists measure in Earth's physical and biological systems (e.g., temperature, extinctions/radiations). The infographic will appear on all website content pages and provides a template for the creation of flowcharts, which are conceptual models that allow teachers and students to visualize the interdependencies and feedbacks among processes in the atmosphere, hydrosphere, biosphere, and geosphere. The development of this resource is timely given that the newly adopted Next Generation Science Standards emphasize cross-cutting concepts, including model building, and Earth system science. Flowchart activities will be available on the website to scaffold inquiry-based lessons, determine student preconceptions, and assess student content knowledge. The infographic has already served as a learning and evaluation tool during professional development workshops at UC Berkeley, Stanford University, and the Smithsonian National Museum of Natural History. At these workshops, scientists and educators used the infographic to highlight how their research and activities reinforce conceptual links among global change topics. Pre- and post-workshop assessment results and responses to questionnaires have guided the refinement of classroom activities and assessment tools utilizing flowcharts as models for global change processes.
Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example.

PubMed

Lai, Zhihong; La Noce, Anna

2016-01-01

The global development of a biosimilar product is a methodologically complex affair, lined with potential design pitfalls and operational missteps to be avoided. Without careful attention to experimental design and meticulous execution, a development programme may fail to demonstrate equivalence, as would be anticipated for a biosimilar product, and not receive regulatory approval based on current guidance. In order to demonstrate similarity of a biosimilar product versus the originator (ie, the branded product), based on regulatory guidance, a stepwise approach is usually taken, starting with a comprehensive structural and functional characterisation of the new biological moiety. Given the sequential nature of the review process, the extent and nature of the non-clinical in vivo studies and the clinical studies to be performed depend on the level of evidence obtained in these previous step(s). A clinical efficacy trial is often required to further demonstrate biosimilarity of the two products (biosimilar vs branded) in terms of comparative safety and effectiveness. Owing to the focus on demonstrating biosimilarity and not safety and efficacy de novo, designing an adequate phase III (potentially pivotal) clinical efficacy study of a biosimilar may present some unique challenges. Using adalimumab as an example, we highlight design elements that may deserve special attention.
Designing effective drug and device development programs for hospitalized heart failure: A proposal for pretrial registries

PubMed Central

Greene, Stephen J.; Shah, Ami N.; Butler, Javed; Ambrosy, Andrew P.; Anker, Stefan D.; Chioncel, Ovidiu; Collins, Sean P.; Dinh, Wilfried; Dunnmon, Preston M.; Fonarow, Gregg C.; Lam, Carolyn S. P.; Mentz, Robert J.; Pieske, Burkert; Roessig, Lothar; Rosano, Giuseppe M. C.; Sato, Naoki; Vaduganathan, Muthiah; Gheorghiade, Mihai

2014-01-01

Recent international phase III clinical trials of novel therapies for hospitalized heart failure (HHF) have failed to improve the unacceptably high postdischarge event rate. These large studies have demonstrated notable geographic and site-specific variation in patient profiles and enrollment. Possible contributors to the lack of success in HHF outcome trials include challenges in selecting clinical sites capable of (1) providing adequate numbers of appropriately selected patients and (2) properly executing the study protocol. We propose a “pretrial registry” as a novel tool for improving the efficiency and quality of international HHF trials by focusing on the selection and cultivation of high-quality sites. A pretrial registry may help assess a site’s ability to achieve adequate enrollment of the target patient population, integrate protocol requirements into clinical workflow, and accomplish appropriate follow-up. Although such a process would be associated with additional upfront resource investment, this appropriation may be modest in comparison with the downstream costs associated with maintenance of poorly performing sites, failed clinical trials, and the global health and economic burden of HHF. This review is based on discussions between scientists, clinical trialists, and regulatory representatives regarding methods for improving international HHF trials that took place at the United States Food and Drug Administration on January 12th, 2012. PMID:25066552
A novel approach to rater training and certification in multinational trials.

PubMed

Jeglic, Elizabeth; Kobak, Kenneth A; Engelhardt, Nina; Williams, Janet B W; Lipsitz, Joshua D; Salvucci, Donna; Bryson, Heather; Bellew, Kevin

2007-07-01

Clinical trials are becoming increasingly international in scope. Global studies pose unique challenges in training and calibrating raters owing to language and cultural differences. Recent findings that poorly conducted interviews reduce study power, makes attention to raters' clinical skills critical. In this study, 109 raters from 14 countries went through a two-step certification process on the Hamilton Depression and Anxiety Rating Scales: (i) an online didactic tutorial on scoring conventions, and (ii) applied clinical training, consisting of small language-specific groups in which raters took turns interviewing patients while observed by an expert trainer, and observation and evaluation of individual interviews. Translators were used when native-language trainers were unavailable. Those who were unable to attend the startup meeting received the training individually via telephone. Results found a significant improvement in raters' knowledge of scoring conventions, with the mean number of correct answers on the 20-item test improving from 14.59 to 17.83, P<0.0001. In addition, raters' clinical skills improved significantly, with the mean score on the Rater Applied Performance Scale improving from their first to their second testing from 10.25 to 11.31, P=0.003. These results support the efficacy of this applied training model in improving raters' applied clinical skills in multinational trials.
Clinical ethics revisited

PubMed Central

Singer, Peter A; Pellegrino, Edmund D; Siegler, Mark

2001-01-01

A decade ago, we reviewed the field of clinical ethics; assessed its progress in research, education, and ethics committees and consultation; and made predictions about the future of the field. In this article, we revisit clinical ethics to examine our earlier observations, highlight key developments, and discuss remaining challenges for clinical ethics, including the need to develop a global perspective on clinical ethics problems. PMID:11346456
Global and local pitch perception in children with developmental dyslexia.

PubMed

Ziegler, Johannes C; Pech-Georgel, Catherine; George, Florence; Foxton, Jessica M

2012-03-01

This study investigated global versus local pitch pattern perception in children with dyslexia aged between 8 and 11 years. Children listened to two consecutive 4-tone pitch sequences while performing a same/different task. On the different trials, sequences either preserved the contour (local condition) or they violated the contour (global condition). Compared to normally developing children, dyslexics showed robust pitch perception deficits in the local but not the global condition. This finding was replicated in a simple pitch direction task, which minimizes sequencing and short term memory. Results are consistent with a left-hemisphere deficit in dyslexia because local pitch changes are supposedly processed by the left hemisphere, whereas global pitch changes are processed by the right hemisphere. The present data suggest a link between impaired pitch processing and abnormal phonological development in children with dyslexia, which makes pitch pattern processing a potent tool for early diagnosis and remediation of dyslexia. Copyright Â© 2011 Elsevier Inc. All rights reserved.
Making Sense of Dynamic Systems: How Our Understanding of Stocks and Flows Depends on a Global Perspective.

PubMed

Fischer, Helen; Gonzalez, Cleotilde

2016-03-01

Stocks and flows (SF) are building blocks of dynamic systems: Stocks change through inflows and outflows, such as our bank balance changing with withdrawals and deposits, or atmospheric CO2 with absorptions and emissions. However, people make systematic errors when trying to infer the behavior of dynamic systems, termed SF failure, whose cognitive explanations are yet unknown. We argue that SF failure appears when people focus on specific system elements (local processing), rather than on the system structure and gestalt (global processing). Using a standard SF task (n = 148), SF failure decreased by (a) a global as opposed to local task format; (b) individual global as opposed to local processing styles; and (c) global as opposed to local perceptual priming. These results converge toward local processing as an explanation for SF failure. We discuss theoretical and practical implications on the connections between the scope of attention and understanding of dynamic systems. Copyright © 2015 Cognitive Science Society, Inc.
Donor human milk banking and the emergence of milk sharing.

PubMed

Landers, Susan; Hartmann, Ben T

2013-02-01

Donor human milk has emerged as the preferred substrate to feed extremely preterm infants, when mother's own milk is unavailable. This article summarizes the clinical data demonstrating the safety, efficacy, and cost-effectiveness of feeding donor human milk to premature babies. It describes the current state of milk banking in North America, as well as other parts of the world, and the differing criteria for donor selection, current pasteurization techniques, and quality control measures. A risk assessment methodology is proposed, which would allow milk banks globally to assess the safety of their process and respond appropriately to differing risk environments. Copyright © 2013. Published by Elsevier Inc.
[Online-gambling - new hazard potential?].

PubMed

Yazdi, Kurosch; Yazdi, Karin

2014-12-01

Since the new American psychiatric classification, DSM V, was released, bringing together substance-related disorders and gambling disorder into one chapter, the addictive potential of gambling and sports wagering is beyond all question. Even the neurobiological processes of the brain show similarities in all addictive disorders. Gambling is more and more shifted into the cyberspace owing to the global expansion of the internet. The addictive potential of online-gambling seems to be higher than offline, though, which is also reflected by the patient population of the outpatient clinic for gambling addiction in Linz. This fact poses a challenge for the persons affected, therapists, gambling providers, legislator the society as a whole.
Nuclear magnetic resonance based metabolomics and liver diseases: Recent advances and future clinical applications.

PubMed

Amathieu, Roland; Triba, Mohamed Nawfal; Goossens, Corentine; Bouchemal, Nadia; Nahon, Pierre; Savarin, Philippe; Le Moyec, Laurence

2016-01-07

Metabolomics is defined as the quantitative measurement of the dynamic multiparametric metabolic response of living systems to pathophysiological stimuli or genetic modification. It is an "omics" technique that is situated downstream of genomics, transcriptomics and proteomics. Metabolomics is recognized as a promising technique in the field of systems biology for the evaluation of global metabolic changes. During the last decade, metabolomics approaches have become widely used in the study of liver diseases for the detection of early biomarkers and altered metabolic pathways. It is a powerful technique to improve our pathophysiological knowledge of various liver diseases. It can be a useful tool to help clinicians in the diagnostic process especially to distinguish malignant and non-malignant liver disease as well as to determine the etiology or severity of the liver disease. It can also assess therapeutic response or predict drug induced liver injury. Nevertheless, the usefulness of metabolomics is often not understood by clinicians, especially the concept of metabolomics profiling or fingerprinting. In the present work, after a concise description of the different techniques and processes used in metabolomics, we will review the main research on this subject by focusing specifically on in vitro proton nuclear magnetic resonance spectroscopy based metabolomics approaches in human studies. We will first consider the clinical point of view enlighten physicians on this new approach and emphasis its future use in clinical "routine".

The Chinese Life-Steps Program: A Cultural Adaptation of a Cognitive-Behavioral Intervention to Enhance HIV Medication Adherence.

PubMed

Shiu, Cheng-Shi; Chen, Wei-Ti; Simoni, Jane; Fredriksen-Goldsen, Karen; Zhang, Fujie; Zhou, Hongxin

2013-05-01

China is considered to be the new frontier of the global AIDS pandemic. Although effective treatment for HIV is becoming widely available in China, adherence to treatment remains a challenge. This study aimed to adapt an intervention promoting HIV-medication adherence-favorably evaluated in the West-for Chinese HIV-positive patients. The adaptation process was theory-driven and covered several key issues of cultural adaptation. We considered the importance of interpersonal relationships and family in China and cultural notions of health. Using an evidence-based treatment protocol originally designed for Western HIV-positive patients, we developed an 11-step Chinese Life-Steps program with an additional culture-specific intervention option. We describe in detail how the cultural elements were incorporated into the intervention and put into practice at each stage. Clinical considerations are also outlined and followed by two case examples that are provided to illustrate our application of the intervention. Finally, we discuss practical and research issues and limitations emerging from our field experiments in a HIV clinic in Beijing. The intervention was tailored to address both universal and culturally specific barriers to adherence and is readily applicable to generalized clinical settings. This evidence-based intervention provides a case example of the process of adapting behavioral interventions to culturally diverse communities with limited resources.
The Chinese Life-Steps Program: A Cultural Adaptation of a Cognitive-Behavioral Intervention to Enhance HIV Medication Adherence

PubMed Central

Shiu, Cheng-Shi; Chen, Wei-Ti; Simoni, Jane; Fredriksen-Goldsen, Karen; Zhang, Fujie; Zhou, Hongxin

2013-01-01

China is considered to be the new frontier of the global AIDS pandemic. Although effective treatment for HIV is becoming widely available in China, adherence to treatment remains a challenge. This study aimed to adapt an intervention promoting HIV-medication adherence—favorably evaluated in the West—for Chinese HIV-positive patients. The adaptation process was theory-driven and covered several key issues of cultural adaptation. We considered the importance of interpersonal relationships and family in China and cultural notions of health. Using an evidence-based treatment protocol originally designed for Western HIV-positive patients, we developed an 11-step Chinese Life-Steps program with an additional culture-specific intervention option. We describe in detail how the cultural elements were incorporated into the intervention and put into practice at each stage. Clinical considerations are also outlined and followed by two case examples that are provided to illustrate our application of the intervention. Finally, we discuss practical and research issues and limitations emerging from our field experiments in a HIV clinic in Beijing. The intervention was tailored to address both universal and culturally specific barriers to adherence and is readily applicable to generalized clinical settings. This evidence-based intervention provides a case example of the process of adapting behavioral interventions to culturally diverse communities with limited resources. PMID:23667305
Impaired global, and compensatory local, biological motion processing in people with high levels of autistic traits.

PubMed

van Boxtel, Jeroen J A; Lu, Hongjing

2013-01-01

People with Autism Spectrum Disorder (ASD) are hypothesized to have poor high-level processing but superior low-level processing, causing impaired social recognition, and a focus on non-social stimulus contingencies. Biological motion perception provides an ideal domain to investigate exactly how ASD modulates the interaction between low and high-level processing, because it involves multiple processing stages, and carries many important social cues. We investigated individual differences among typically developing observers in biological motion processing, and whether such individual differences associate with the number of autistic traits. In Experiment 1, we found that individuals with fewer autistic traits were automatically and involuntarily attracted to global biological motion information, whereas individuals with more autistic traits did not show this pre-attentional distraction. We employed an action adaptation paradigm in the second study to show that individuals with more autistic traits were able to compensate for deficits in global processing with an increased involvement in local processing. Our findings can be interpreted within a predictive coding framework, which characterizes the functional relationship between local and global processing stages, and explains how these stages contribute to the perceptual difficulties associated with ASD.
Impaired Global, and Compensatory Local, Biological Motion Processing in People with High Levels of Autistic Traits

PubMed Central

van Boxtel, Jeroen J. A.; Lu, Hongjing

2013-01-01

People with Autism Spectrum Disorder (ASD) are hypothesized to have poor high-level processing but superior low-level processing, causing impaired social recognition, and a focus on non-social stimulus contingencies. Biological motion perception provides an ideal domain to investigate exactly how ASD modulates the interaction between low and high-level processing, because it involves multiple processing stages, and carries many important social cues. We investigated individual differences among typically developing observers in biological motion processing, and whether such individual differences associate with the number of autistic traits. In Experiment 1, we found that individuals with fewer autistic traits were automatically and involuntarily attracted to global biological motion information, whereas individuals with more autistic traits did not show this pre-attentional distraction. We employed an action adaptation paradigm in the second study to show that individuals with more autistic traits were able to compensate for deficits in global processing with an increased involvement in local processing. Our findings can be interpreted within a predictive coding framework, which characterizes the functional relationship between local and global processing stages, and explains how these stages contribute to the perceptual difficulties associated with ASD. PMID:23630514
Is manipulation of color effective in study of the global precedence effect?

PubMed

Vidal-López, Joaquín; Romera-Vivancos, Juan Antonio

2009-04-01

This article evaluates the use of color manipulation in studying the effect of global precedence and the possible involvement of the magnocellular processing system. The analysis shows variations of color used in three studies produced changes on the global precedence effect, but findings based on this technique present some methodological problems and have little theoretical support from the magnocellular processing-system perspective. For this reason, more research is required to develop knowledge about the origin of these variations in global precedence.
Creating Intentional Spaces for Sustainable Development in the Indian Trans-Himalaya: Reconceptualizing Globalization from Below

ERIC Educational Resources Information Center

Shah, Payal

2014-01-01

In an era of globalization, multifaceted and complex changes have increasingly interconnected geographically dispersed places. A central question of globalization studies concerns whether top-down forces of globalization are forging a global culture or whether processes of globalization from below are able to push back against homogenization by…
Infections are a global issue: infection addresses global issues.

PubMed

Grobusch, M P; Calleri, G; Bogner, J R

2012-12-01

Infections are of unifying global concern, despite regional differences in disease epidemiology, clinical appearance and the instruments to tackle them. The primary aim of Infection is "to be a forum for the presentation and discussion of clinically relevant information on infectious diseases… from all over the world". To that end, and as a reflection of the global burden of infectious diseases, we intend to increase the number of high-quality contributions from authors addressing the aetiology, pathogenesis, diagnosis and treatment of infectious diseases from outside Europe and the affluent North (Chang et al. Infection 40:359-365, 2012; Misra et al. Infection 40:125-130, 2012). The Editorial Board of Infection envisages the journal as an interface between where infectious diseases meet and mix between "North and South"--i.e., the field of travel medicine--frequently functioning as a sentinel for altered/novel disease activities that are encountered as imported conditions. With the change in generation on the Editorial Board, Infection aims to expand the areas of tropical medicine, travel medicine and global health with its own section editors (GC and MPG). Contributions from outside Europe are actively encouraged.
Korean Medication Algorithm for Depressive Disorder: Comparisons with Other Treatment Guidelines

PubMed Central

Wang, Hee Ryung; Bahk, Won-Myong; Seo, Jeong Seok; Woo, Young Sup; Park, Young-Min; Jeong, Jong-Hyun; Kim, Won; Shim, Se-Hoon; Lee, Jung Goo; Jon, Duk-In; Min, Kyung Joon

2017-01-01

In this review, we compared recommendations from the Korean Medication Algorithm Project for Depressive Disorder 2017 (KMAP-DD 2017) to other global treatment guidelines for depression. Six global treatment guidelines were reviewed; among the six, 4 were evidence-based guidelines, 1 was an expert consensus-based guideline, and 1 was an amalgamation of both evidence and expert consensus-based recommendations. The recommendations in the KMAP-DD 2017 were generally similar to those in other global treatment guidelines, although there were some differences between the guidelines. The KMAP-DD 2017 appeared to reflect current changes in the psychopharmacology of depression quite well, like other recently published evidence-based guidelines. As an expert consensus-based guideline, the KMAP-DD 2017 had some limitations. However, considering there are situations in which clinical evidence cannot be drawn from planned clinical trials, the KMAP-DD 2017 may be helpful for Korean psychiatrists making decisions in the clinical settings by complementing previously published evidence-based guidelines. PMID:28783928
Zooming into creativity: individual differences in attentional global-local biases are linked to creative thinking.

PubMed

Zmigrod, Sharon; Zmigrod, Leor; Hommel, Bernhard

2015-01-01

While recent studies have investigated how processes underlying human creativity are affected by particular visual-attentional states, we tested the impact of more stable attention-related preferences. These were assessed by means of Navon's global-local task, in which participants respond to the global or local features of large letters constructed from smaller letters. Three standard measures were derived from this task: the sizes of the global precedence effect, the global interference effect (i.e., the impact of incongruent letters at the global level on local processing), and the local interference effect (i.e., the impact of incongruent letters at the local level on global processing). These measures were correlated with performance in a convergent-thinking creativity task (the Remote Associates Task), a divergent-thinking creativity task (the Alternate Uses Task), and a measure of fluid intelligence (Raven's matrices). Flexibility in divergent thinking was predicted by the local interference effect while convergent thinking was predicted by intelligence only. We conclude that a stronger attentional bias to visual information about the "bigger picture" promotes cognitive flexibility in searching for multiple solutions.
Dipeptidyl Peptidase-4 Inhibitor Development and Post-authorisation Programme for Vildagliptin - Clinical Evidence for Optimised Management of Chronic Diseases Beyond Type 2 Diabetes.

PubMed

Strain, William David; Paldánius, Päivi M

2017-08-01

The last decade has witnessed the role of dipeptidyl peptidase-4 (DPP-4) inhibitors in producing a conceptual change in early management of type 2 diabetes mellitus (T2DM) by shifting emphasis from a gluco-centric approach to holistically treating underlying pathophysiological processes. DPP-4 inhibitors highlighted the importance of acknowledging hypoglycaemia and weight gain as barriers to optimised care in T2DM. These complications were an integral part of diabetes management before the introduction of DPP-4 inhibitors. During the development of DPP-4 inhibitors, regulatory requirements for introducing new agents underwent substantial changes, with increased emphasis on safety. This led to the systematic collection of adjudicated cardiovascular (CV) safety data, and, where 95% confidence of a lack of harm could not be demonstrated, the standardised CV safety studies. Furthermore, the growing awareness of the worldwide extent of T2DM demanded a more diverse approach to recruitment and participation in clinical trials. Finally, the global financial crisis placed a new awareness on the health economics of diabetes, which rapidly became the most expensive disease in the world. This review encompasses unique developments in the global landscape, and the role DPP-4 inhibitors, specifically vildagliptin, have played in research advancement and optimisation of diabetes care in a diverse population with T2DM worldwide.
Estimated Glomerular Filtration Rate; Laboratory Implementation and Current Global Status.

PubMed

Miller, W Greg; Jones, Graham R D

2018-01-01

In 2002, the Kidney Disease Outcomes Quality Initiative guidelines for identifying and treating CKD recommended that clinical laboratories report estimated glomerular filtration rate (eGFR) with every creatinine result to assist clinical practitioners to identify people with early-stage CKD. At that time, the original Modification of Diet in Renal Disease (MDRD) Study equation based on serum creatinine measurements was recommended for calculating eGFR. Because the MDRD Study equation was developed using a nonstandardized creatinine method, a Laboratory Working Group of the National Kidney Disease Education program was formed and implemented standardized calibration traceability for all creatinine methods from global manufacturers by approximately 2010. A modified MDRD Study equation for use with standardized creatinine was developed. The Chronic Kidney Disease Epidemiology Collaboration developed a new equation in 2009 that was more accurate than the MDRD Study equation at values above 60 mL/min/1.73 m 2 . As of 2017, reporting eGFR with creatinine is almost universal in many countries. A reference system for cystatin C became available in 2010, and manufacturers are in the process to standardize cystatin C assays. Equations for eGFR based on standardized cystatin C alone and with creatinine are now available from the Chronic Kidney Disease Epidemiology Collaboration and other groups. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.
Dipeptidyl Peptidase-4 Inhibitor Development and Post-authorisation Programme for Vildagliptin — Clinical Evidence for Optimised Management of Chronic Diseases Beyond Type 2 Diabetes

PubMed Central

Paldánius, Päivi M

2017-01-01

Abstract The last decade has witnessed the role of dipeptidyl peptidase-4 (DPP-4) inhibitors in producing a conceptual change in early management of type 2 diabetes mellitus (T2DM) by shifting emphasis from a gluco-centric approach to holistically treating underlying pathophysiological processes. DPP-4 inhibitors highlighted the importance of acknowledging hypoglycaemia and weight gain as barriers to optimised care in T2DM. These complications were an integral part of diabetes management before the introduction of DPP-4 inhibitors. During the development of DPP-4 inhibitors, regulatory requirements for introducing new agents underwent substantial changes, with increased emphasis on safety. This led to the systematic collection of adjudicated cardiovascular (CV) safety data, and, where 95% confidence of a lack of harm could not be demonstrated, the standardised CV safety studies. Furthermore, the growing awareness of the worldwide extent of T2DM demanded a more diverse approach to recruitment and participation in clinical trials. Finally, the global financial crisis placed a new awareness on the health economics of diabetes, which rapidly became the most expensive disease in the world. This review encompasses unique developments in the global landscape, and the role DPP-4 inhibitors, specifically vildagliptin, have played in research advancement and optimisation of diabetes care in a diverse population with T2DM worldwide. PMID:29632609
Quality of data gathered with International Caries Detection and Assessment System (ICDAS) assessment and dentists' perceptions of completion of dental records.

PubMed

Aidara, Adjaratou W; Pitts, Nigel; Markowska, Neda; Bourgeois, Denis

2011-12-01

The FDI World Dental Federation is engaged in a global consultation process to assess the potential challenges and impacts of the introduction of a preventive model to existing systems for caries management. The aims of this study were to evaluate the quality of dental disease data collected with the International Caries Detection and Assessment System (ICDAS) index and dentists' perceptions with regard to the collection of data using the 'European Global Oral Health Indicators Development' (EGOHID) survey methods, and to estimate the mean time required for completion of the dental records according to the practitioners' perceptions. The data - 2877 clinical examinations and 2877 individual assessments - were collected in 2008 using a network of 146 sentinel dentists in eight European countries. A clinical survey was completed for each participant and the dentist gave a detailed assessment of each patient investigated. This study shows that practitioners' perceptions have an impact on the mean time required to complete the dental record. Mistakes originate from dentists' attempts to simplify the completion of many boxes. This results in a larger number of missing data than of error codes. These missing data have an effect on the time required for information collection. The quality of the data collected will allow the establishment of recommendations based on this method. © 2011 FDI World Dental Federation.
Integration of local motion is normal in amblyopia

NASA Astrophysics Data System (ADS)

Hess, Robert F.; Mansouri, Behzad; Dakin, Steven C.; Allen, Harriet A.

2006-05-01

We investigate the global integration of local motion direction signals in amblyopia, in a task where performance is equated between normal and amblyopic eyes at the single element level. We use an equivalent noise model to derive the parameters of internal noise and number of samples, both of which we show are normal in amblyopia for this task. This result is in apparent conflict with a previous study in amblyopes showing that global motion processing is defective in global coherence tasks [Vision Res. 43, 729 (2003)]. A similar discrepancy between the normalcy of signal integration [Vision Res. 44, 2955 (2004)] and anomalous global coherence form processing has also been reported [Vision Res. 45, 449 (2005)]. We suggest that these discrepancies for form and motion processing in amblyopia point to a selective problem in separating signal from noise in the typical global coherence task.
Preliminary data on ASP2215: tolerability and efficacy in acute myeloid leukemia patients.

PubMed

Thom, Claire

2015-09-01

Claire Thom speaks to Gemma Westcott, Commissioning Editor: Claire Thom joined Astellas in 2013 as the Therapeutic Area Head for Oncology in Global Development. In that role, she also serves as the STAR leader for Oncology for Astellas. Prior to Astellas, she spent 12 years with Takeda. Her last position was Senior Vice President, Portfolio Management, Drug Development Management and Medical Informatics and Strategic Operations within the Medical Division (the Division within Millennium responsible for oncology clinical drug development within Takeda). During her 4 years at Millennium, at various times, she had responsibility within the Medical Division for leading portfolio management, business operations (medical finance, annual and mid-range financial planning, space planning and operations, headcount resourcing, development goals process), clinical development operations (clinical operations, programming, data management, statistics, medical writing, clinical outsourcing), drug development management (project management), medical informatics (technology support for the division) and the strategic project management office for the division. Prior to joining Millennium, Claire Thom spent 18 months working in Osaka, Japan, during which she was responsible for developing the oncology strategy for Takeda that culminated in the acquisition of Millennium. Before going to Japan, she held positions of varying responsibility within the Takeda US development organization including the management of regulatory affairs, safety, biometrics and data management, clinical research and quality assurance. Claire Thom has particular expertise in organizational design and efficiency; she has successfully worked through integrations across multiple functions and redesigned business processes. She has a PharmD from University of Illinois (IL, USA) and over 20 years of pharmaceutical experience including positions in medical affairs and new product planning (over 11 years at Searle) and drug development (over 12 years at Takeda/Millennium).
[First SIBEN clinical consensus: diagnostic and therapeutic approach to patent ductus arteriosus in premature newborns].

PubMed

Golombek, S G; Sola, A; Baquero, H; Borbonet, D; Cabañas, F; Fajardo, C; Goldsmit, G; Lemus, L; Miura, E; Pellicer, A; Pérez, J M; Rogido, M; Zambosco, G; van Overmeire, B

2008-11-01

To report the process and results of the first neonatal clinical consensus of the Ibero-American region. Two recognized experts in the field (Clyman and Van Overmeire) and 45 neonatologists from 23 countries were invited for active participation and collaboration. We developed 46 questions of clinical-physiological relevance in all aspects of patent ductus arteriosus (PDA). Guidelines for consensus process, literature search and future preparation of educational material and authorship were developed, reviewed and agreed by all. Participants from different countries were distributed in groups, and assigned to interact and work together to answer 3-5 questions, reviewing all global literature and local factors. Answers and summaries were received, collated and reviewed by 2 coordinators and the 2 experts. Participants and experts met in Granada, Spain for 4.5 h (lectures by experts, presentations by groups, discussion, all literature available). 31 neonatologists from 16 countries agreed to participate. Presentations by each group and general discussion were used to develop a consensus regarding: general management, availability of drugs (indomethacin vs. ibuprofen), costs, indications for echo/surgery, etc. Many steps were learnt by all present in a collaborative forum. This first consensus group of Ibero-American neonatologists SIBEN led to active and collaborative participation of neonatologists of 16 countries, improved education of all participants and ended with consensus development on clinical approaches to PDA. Furthermore, it provides recommendations for clinical care reached by consensus. Additionally, it will serve as a useful foundation for future SIBEN Consensus on other topics and it could become valuable as a model to decrease disparity in care and improve outcomes in this and other regions.
Challenges in developing national HIV guidelines: experience from the eastern Mediterranean

PubMed Central

De Weggheleire, Anja; Bortolotti, Veronique; Zolfo, Maria; Crowley, Siobhan; Colebunders, Robert; Riedner, Gabriele

2011-01-01

Abstract Objective To appraise the process of development and clinical content of national human immunodeficiency virus (HIV) clinical practice guidelines of countries in the eastern Mediterranean and to formulate recommendations for future guideline development and adaptation. Methods Twenty-three countries in the World Health Organization (WHO) Eastern Mediterranean and United Nations Children’s Fund Middle East and North Africa regions were invited to submit national HIV clinical practice guidelines for review. The guideline development methodology was assessed using an adaptation of the Appraisal of Guidelines Research and Evaluation (AGREE) instrument and guideline content, using a checklist to evaluate concordance with WHO 2006 generic guidelines. Findings Twelve countries submitted 20 guidelines developed between 2004 and 2009. Median scores were poor (i.e. < 0.6) for the methodological quality domains of rigour of development, stakeholder involvement and applicability and flexibility. Scores were better for the domains of scope and purpose (median: 0.82, interquartile range, IQR: 0.58–0.89) and clarity and presentation (median: 0.67, IQR: 0.50–0.78). Concerning guideline content, recommended first-line treatment and eligibility criteria for antiretroviral therapy (ART) in adults were in line with WHO recommendations in most guidelines. However, recommendations on antiretroviral prophylaxis for the prevention of vertical HIV transmission, diagnosis and treatment of HIV infection in infants, monitoring patients on ART, treatment failure and co-morbidities were often lacking. Conclusion The large majority of national HIV clinical practice guidelines had methodological weaknesses and content inaccuracies. Countries require assistance with the adaptation process to ensure that guidelines are valid and up to date and accurately reflect WHO global clinical care recommendations for patients with HIV. PMID:21673860
Promoting the Self-Regulation of Clinical Reasoning Skills in Nursing Students

PubMed Central

Kuiper, R; Pesut, D; Kautz, D

2009-01-01

Aim: The purpose of this paper is to describe the research surrounding the theories and models the authors united to describe the essential components of clinical reasoning in nursing practice education. The research was conducted with nursing students in health care settings through the application of teaching and learning strategies with the Self-Regulated Learning Model (SRL) and the Outcome-Present-State-Test (OPT) Model of Reflective Clinical Reasoning. Standardized nursing languages provided the content and clinical vocabulary for the clinical reasoning task. Materials and Methods: This descriptive study described the application of the OPT model of clinical reasoning, use of nursing language content, and reflective journals based on the SRL model with 66 undergraduate nursing students over an 8 month period of time. The study tested the idea that self-regulation of clinical reasoning skills can be developed using self-regulation theory and the OPT model. Results: This research supports a framework for effective teaching and learning methods to promote and document learner progress in mastering clinical reasoning skills. Self-regulated Learning strategies coupled with the OPT model suggest benefits of self-observation and self-monitoring during clinical reasoning activities, and pinpoints where guidance is needed for the development of cognitive and metacognitive awareness. Recommendations and Conclusions: Thinking and reasoning about the complexities of patient care needs requires attention to the content, processes and outcomes that make a nursing care difference. These principles and concepts are valuable to clinical decision making for nurses globally as they deal with local, regional, national and international health care issues. PMID:19888432
Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings.

PubMed

Mtove, George; Kimani, Joshua; Kisinza, William; Makenga, Geofrey; Mangesho, Peter; Duparc, Stephan; Nakalembe, Miriam; Phiri, Kamija S; Orrico, Russell; Rojo, Ricardo; Vandenbroucke, Pol

2018-03-22

Multinational clinical trials are logistically complex and require close coordination between various stakeholders. They must comply with global clinical standards and are accountable to multiple regulatory and ethical bodies. In resource-limited settings, it is challenging to understand how to apply global clinical standards to international, national, and local factors in clinical trials, making multiple-level stakeholder engagement an important element in the successful conduct of these clinical trials. During the planning and implementation of a large multinational clinical trial for intermittent preventive treatment of malaria in pregnancy in resource-limited areas of sub-Saharan Africa, we encountered numerous challenges, which required implementation of a range of engagement measures to ensure compliance with global clinical and regulatory standards. These challenges included coordination with ongoing global malaria efforts, heterogeneity in national regulatory structures, sub-optimal healthcare infrastructure, local practices and beliefs, and perspectives that view healthcare providers with undue trust or suspicion. In addition to engagement with international bodies, such as the World Health Organization, the Malaria in Pregnancy Consortium, the Steve Biko Centre for Bioethics, and the London School of Hygiene and Tropical Medicine, in order to address the challenges just described, Pfizer Inc. and Medicines for Malaria Venture (the "Sponsoring Entities" for these studies) and investigators liaised with national- and district-level stakeholders such as health ministers and regional/local community health workers. Community engagement measures undertaken by investigators included local meetings with community leaders to explain the research aims and answer questions and concerns voiced by the community. The investigators also engaged with family members of prospective trial participants in order to be sensitive to local practices and beliefs. Engagement with key stakeholders at international and national levels enabled the Sponsoring Entities to address challenges by aligning the study design with the requirements of health and regulatory agencies and to understand and address healthcare infrastructure needs prior to trial initiation. Local stakeholder engagement, including community members, study participants, and family enabled the investigators to address challenges by ensuring that study design and conduct were adapted to local considerations and ensuring accurate information about the study aims was shared with the public. ClinicalTrials.gov, ID: NCT01103063 . Registered on 7 April 2010.
Global conjecturing process in pattern generalization problem

NASA Astrophysics Data System (ADS)

Sutarto; Nusantara, Toto; Subanji; Dwi Hastuti, Intan; Dafik

2018-04-01

The aim of this global conjecturing process based on the theory of APOS. The subjects used in study were 15 of 8th grade students of Junior High School. The data were collected using Pattern Generalization Problem (PGP) and interviews. After students had already completed PGP; moreover, they were interviewed using students work-based to understand the conjecturing process. These interviews were video taped. The result of study reveals that the global conjecturing process occurs at the phase of action in which subjects build a conjecture by observing and counting the number of squares completely without distinguishing between black or white squares, finaly at the phase of process, the object and scheme were perfectly performed.

Evidence for global processing of complex visual displays

NASA Technical Reports Server (NTRS)

Munson, Robert C.; Horst, Richard L.

1986-01-01

'Polar graphic' displays, in which changes in system status are represented by distortions in the form of a geometric figure, were presented to subjects, and reaction time (RT) to discriminate system status was recorded. Of interest was the extent to which reaction time showed evidence of global processing of these displays as the number of nodes and difficulty of discrimination were varied. When discrimination of system status was easy, RT showed no increase with increasing number of nodes, providing evidence of global processing. When discrimination was difficult, systematic differences in RT as a function of the number of nodes suggested the invocation of other (local) processes, although the data were not consistent with a node-by-node search process.
Under the (legal) radar screen: global health initiatives and international human rights obligations.

PubMed

Hammonds, Rachel; Ooms, Gorik; Vandenhole, Wouter

2012-11-15

Given that many low income countries are heavily reliant on external assistance to fund their health sectors the acceptance of obligations of international assistance and cooperation with regard to the right to health (global health obligations) is insufficiently understood and studied by international health and human rights scholars. Over the past decade Global Health Initiatives, like the Global Fund to fight AIDS, Tuberculosis and Malaria (Global Fund) have adopted novel approaches to engaging with stakeholders in high and low income countries. This article explores how this experience impacted on acceptance of the international obligation to (help) fulfil the right to health beyond borders. The authors conducted an extensive review of international human rights law literature, transnational legal process literature, global public health literature and grey literature pertaining to Global Health Initiatives. To complement this desk work and deepen their understanding of how and why different legal norms evolve the authors conducted 19 in-depth key informant interviews with actors engaged with three stakeholders; the European Union, the United States and Belgium. The authors then analysed the interviews through a transnational legal process lens. Through according value to the process of examining how and why different legal norms evolve transnational legal process offers us a tool for engaging with the dynamism of developments in global health suggesting that operationalising global health obligations could advance the right to health for all. In many low-income countries the health sector is heavily dependent on external assistance to fulfil the right to health of people thus it is vital that policies and tools for delivering reliable, long-term assistance are developed so that the right to health for all becomes more than a dream. Our research suggests that the Global Fund experience offers lessons to build on.
Compensatory mechanisms in higher-educated subjects with Alzheimer's disease: a study of 20 years of cognitive decline.

PubMed

Amieva, Hélène; Mokri, Hind; Le Goff, Mélanie; Meillon, Céline; Jacqmin-Gadda, Hélène; Foubert-Samier, Alexandra; Orgogozo, Jean-Marc; Stern, Yaakov; Dartigues, Jean-François

2014-04-01

A better knowledge of long-term trajectories of cognitive decline is a central feature of the study of the process leading to Alzheimer's dementia. Several factors may mitigate such decline, among which is education, a major risk factor for Alzheimer's disease. The aim of our work was to compare the pattern and duration of clinical trajectories before Alzheimer's dementia in individuals with low and high education within the PAQUID cohort involving 20 years of follow-up. The sample comprises 442 participants with incident Alzheimer's disease (27.2% were male)--171 with low education (mean age=86.2 years; standard deviation=5.3 years) and 271 with higher education (mean age=86.5; standard deviation=5.4)--and 442 control subjects matched according to age, sex and education. At each visit and up to the 20-year follow-up visit, several cognitive and clinical measures were collected and incident cases of Alzheimer's disease clinically diagnosed. The evolution of clinical measures in pre-demented subjects and matched controls was analysed with a semi-parametric extension of the mixed effects linear model. The results show that the first signs of cognitive decline occurred 15 to 16 years before achieving dementia threshold in higher-educated subjects whereas signs occurred at 7 years before dementia in low-educated subjects. There seemed to be two successive periods of decline in higher-educated subjects. Decline started ∼15 to 16 years before dementia with subtle impairment restricted to some cognitive tests and with no impact during the first 7 to 8 years on global cognition, cognitive complaints, or activities of daily living scales. Then, ∼7 years before dementia, global cognitive abilities begin to deteriorate, along with difficulties dealing with complex activities of daily living, the increase in self-perceived difficulties and depressive symptoms. By contrast, lower-educated subjects presented a single period of decline lasting ∼7 years, characterized by decline concomitantly affecting specific and more global cognitive function along with alteration in functional abilities. This study demonstrates how early cognitive symptoms may emerge preceding Alzheimer's dementia particularly in higher-educated individuals, for whom decline occurred up to 16 years before dementia. It also demonstrates the protective role of education in the clinical trajectory preceding Alzheimer's dementia. We suggest that the initial decline in cognition occurs at the onset of comparable Alzheimer's disease pathology in both groups, and is associated with immediate decline to dementia in the lower education group. In contrast, higher education protects against further cognitive decline for ∼7 years until pathology becomes more severe.
Barriers to using eHealth data for clinical performance feedback in Malawi: A case study.

PubMed

Landis-Lewis, Zach; Manjomo, Ronald; Gadabu, Oliver J; Kam, Matthew; Simwaka, Bertha N; Zickmund, Susan L; Chimbwandira, Frank; Douglas, Gerald P; Jacobson, Rebecca S

2015-10-01

Sub-optimal performance of healthcare providers in low-income countries is a critical and persistent global problem. The use of electronic health information technology (eHealth) in these settings is creating large-scale opportunities to automate performance measurement and provision of feedback to individual healthcare providers, to support clinical learning and behavior change. An electronic medical record system (EMR) deployed in 66 antiretroviral therapy clinics in Malawi collects data that supervisors use to provide quarterly, clinic-level performance feedback. Understanding barriers to provision of eHealth-based performance feedback for individual healthcare providers in this setting could present a relatively low-cost opportunity to significantly improve the quality of care. The aims of this study were to identify and describe barriers to using EMR data for individualized audit and feedback for healthcare providers in Malawi and to consider how to design technology to overcome these barriers. We conducted a qualitative study using interviews, observations, and informant feedback in eight public hospitals in Malawi where an EMR system is used. We interviewed 32 healthcare providers and conducted seven hours of observation of system use. We identified four key barriers to the use of EMR data for clinical performance feedback: provider rotations, disruptions to care processes, user acceptance of eHealth, and performance indicator lifespan. Each of these factors varied across sites and affected the quality of EMR data that could be used for the purpose of generating performance feedback for individual healthcare providers. Using routinely collected eHealth data to generate individualized performance feedback shows potential at large-scale for improving clinical performance in low-resource settings. However, technology used for this purpose must accommodate ongoing changes in barriers to eHealth data use. Understanding the clinical setting as a complex adaptive system (CAS) may enable designers of technology to effectively model change processes to mitigate these barriers. Copyright © 2015. Published by Elsevier Ireland Ltd.
Barriers to using eHealth data for clinical performance feedback in Malawi: A case study

PubMed Central

Landis-Lewis, Zach; Manjomo, Ronald; Gadabu, Oliver J; Kam, Matthew; Simwaka, Bertha N; Zickmund, Susan L; Chimbwandira, Frank; Douglas, Gerald P; Jacobson, Rebecca S

2016-01-01

Introduction Sub-optimal performance of healthcare providers in low-income countries is a critical and persistent global problem. The use of electronic health information technology (eHealth) in these settings is creating large-scale opportunities to automate performance measurement and provision of feedback to individual healthcare providers, to support clinical learning and behavior change. An electronic medical record system (EMR) deployed in 66 antiretroviral therapy clinics in Malawi collects data that supervisors use to provide quarterly, clinic-level performance feedback. Understanding barriers to provision of eHealth-based performance feedback for individual healthcare providers in this setting could present a relatively low-cost opportunity to significantly improve the quality of care. Objective The aims of this study were to identify and describe barriers to using EMR data for individualized audit and feedback for healthcare providers in Malawi and to consider how to design technology to overcome these barriers. Methods We conducted a qualitative study using interviews, observations, and informant feedback in eight public hospitals in Malawi where an EMR is used. We interviewed 32 healthcare providers and conducted seven hours of observation of system use. Results We identified four key barriers to the use of EMR data for clinical performance feedback: provider rotations, disruptions to care processes, user acceptance of eHealth, and performance indicator lifespan. Each of these factors varied across sites and affected the quality of EMR data that could be used for the purpose of generating performance feedback for individual healthcare providers. Conclusion Using routinely collected eHealth data to generate individualized performance feedback shows potential at large-scale for improving clinical performance in low-resource settings. However, technology used for this purpose must accommodate ongoing changes in barriers to eHealth data use. Understanding the clinical setting as a complex adaptive system (CAS) may enable designers of technology to effectively model change processes to mitigate these barriers. PMID:26238704
The anterior hippocampus supports a coarse, global environmental representation and the posterior hippocampus supports fine-grained, local environmental representations.

PubMed

Evensmoen, Hallvard Røe; Lehn, Hanne; Xu, Jian; Witter, Menno P; Nadel, Lynn; Håberg, Asta K

2013-11-01

Representing an environment globally, in a coarse way, and locally, in a fine-grained way, are two fundamental aspects of how our brain interprets the world that surrounds us. The neural correlates of these representations have not been explicated in humans. In this study we used fMRI to investigate these correlates and to explore a possible functional segregation in the hippocampus and parietal cortex. We hypothesized that processing a coarse, global environmental representation engages anterior parts of these regions, whereas processing fine-grained, local environmental information engages posterior parts. Participants learned a virtual environment and then had to find their way during fMRI. After scanning, we assessed strategies used and representations stored. Activation in the hippocampal head (anterior) was related to the multiple distance and global direction judgments and to the use of a coarse, global environmental representation during navigation. Activation in the hippocampal tail (posterior) was related to both local and global direction judgments and to using strategies like number of turns. A structural shape analysis showed that the use of a coarse, global environmental representation was related to larger right hippocampal head volume and smaller right hippocampal tail volume. In the inferior parietal cortex, a similar functional segregation was observed, with global routes represented anteriorly and fine-grained route information such as number of turns represented posteriorly. In conclusion, moving from the anterior to the posterior hippocampus and inferior parietal cortex reflects a shift from processing coarse global environmental representations to processing fine-grained, local environmental representations.
The Development of Global and Local Processing: A Comparison of Children to Adults

ERIC Educational Resources Information Center

Peterson, Eric; Peterson, Robin L.

2014-01-01

In light of the adult model of a hemispheric asymmetry of global and local processing, we compared children (M [subscript age] = 8.4 years) to adults in a global-local reaction time (RT) paradigm. Hierarchical designs (large shapes made of small shapes) were presented randomly to each visual field, and participants were instructed to identify…
Visual Attention to Global and Local Stimulus Properties in 6-Month-Old Infants: Individual Differences and Event-Related Potentials

ERIC Educational Resources Information Center

Guy, Maggie W.; Reynolds, Greg D.; Zhang, Dantong

2013-01-01

Event-related potentials (ERPs) were utilized in an investigation of 21 six-month-olds' attention to and processing of global and local properties of hierarchical patterns. Overall, infants demonstrated an advantage for processing the overall configuration (i.e., global properties) of local features of hierarchical patterns; however,…
Common social cognitive impairments do not mean common causes: A commentary on Cotter et al. (2018).

PubMed

Dodell-Feder, David; Germine, Laura T

2018-06-06

Many clinical conditions, ranging from psychiatric to neurodegenerative illnesses, are associated with impairments in the processes by which we perceive, interpret, and respond to social information; a suite of abilities known as social cognition. Through a systematic review of meta-analyses, Cotter et al. (2018) present a compelling view of social cognitive deficits as a core phenotype of many clinical conditions. However, we caution against one potential interpretation of their findings, namely, that similar social cognitive outcomes are produced by similar causes. Specifically, we argue that while the outcome may look similar across clinical conditions (i.e., global social cognitive deficits), the cause and nature of those impairments are likely to differ, and, as a consequence, so too will its remediation. We advocate for the development of better methods for assessing social cognition, which may speak to the varying nature of social cognitive impairment across conditions. Ultimately, a better understanding of how social cognition is impaired will facilitate the development of more targeted, more effective treatments, that will improve patient care. Copyright © 2018 Elsevier Ltd. All rights reserved.
Childhood Depression: Relation to Adaptive, Clinical and Predictor Variables

PubMed Central

Garaigordobil, Maite; Bernarás, Elena; Jaureguizar, Joana; Machimbarrena, Juan M.

2017-01-01

The study had two goals: (1) to explore the relations between self-assessed childhood depression and other adaptive and clinical variables (2) to identify predictor variables of childhood depression. Participants were 420 students aged 7–10 years old (53.3% boys, 46.7% girls). Results revealed: (1) positive correlations between depression and clinical maladjustment, school maladjustment, emotional symptoms, internalizing and externalizing problems, problem behaviors, emotional reactivity, and childhood stress; and (2) negative correlations between depression and personal adaptation, global self-concept, social skills, and resilience (sense of competence and affiliation). Linear regression analysis including the global dimensions revealed 4 predictors of childhood depression that explained 50.6% of the variance: high clinical maladjustment, low global self-concept, high level of stress, and poor social skills. However, upon introducing the sub-dimensions, 9 predictor variables emerged that explained 56.4% of the variance: many internalizing problems, low family self-concept, high anxiety, low responsibility, low personal self-assessment, high social stress, few aggressive behaviors toward peers, many health/psychosomatic problems, and external locus of control. The discussion addresses the importance of implementing prevention programs for childhood depression at early ages. PMID:28572787
Family Life and Social Medicine: Discourses and Discontents Surrounding Puebla's Psychiatric Care.

PubMed

Hale, Kathryn Law

2017-12-01

Drawing on clinical data from 15 months of on-site participant observation in the only public psychiatric hospital in the state of Puebla, Mexico, this article advances our understanding of globalization in relation to psychiatry. I challenge the construction of psychiatry as only treating the individual patient and provide grounded doctor-patient-family member interaction in a Mexican psychiatric clinic in order to review what happens when doctors cannot interact with patients as atomized individuals even though in theory they are trained to think of patients that way. Challenged by severe structural constraints and bolstered by lessons from other nations' efforts at deinstitutionalization, psychiatrists in Puebla push to keep patients out of the inpatient wards and in their respective communities. To this end, psychiatrists call upon co-present kin who are identified both as the customer and part of the caretaking system outside the clinic. This modification to the visit structure changes the dynamic and content of clinical visits while doctors seamlessly respond to unspoken beliefs and values that are central to local life, ultimately showing that efforts to define a "global psychiatry" informed by global policy will fail because it cannot exist in a uniform way-interpersonal interaction and personal experience matters.
Initiating a Human Variome Project Country Node.

PubMed

AlAama, Jumana; Smith, Timothy D; Lo, Alan; Howard, Heather; Kline, Alexandria A; Lange, Matthew; Kaput, Jim; Cotton, Richard G H

2011-05-01

Genetic diseases are a pressing global health problem that requires comprehensive access to basic clinical and genetic data to counter. The creation of regional and international databases that can be easily accessed by clinicians and diagnostic labs will greatly improve our ability to accurately diagnose and treat patients with genetic disorders. The Human Variome Project is currently working in conjunction with human genetics societies to achieve this by establishing systems to collect every mutation reported by a diagnostic laboratory, clinic, or research laboratory in a country and store these within a national repository, or HVP Country Node. Nodes have already been initiated in Australia, Belgium, China, Egypt, Malaysia, and Kuwait. Each is examining how to systematically collect and share genetic, clinical, and biochemical information in a country-specific manner that is sensitive to local ethical and cultural issues. This article gathers cases of genetic data collection within countries and takes recommendations from the global community to develop a procedure for countries wishing to establish their own collection system as part of the Human Variome Project. We hope this may lead to standard practices to facilitate global collection of data and allow efficient use in clinical practice, research and therapy. © 2011 Wiley-Liss, Inc.
Diagnosis of gluten related disorders: Celiac disease, wheat allergy and non-celiac gluten sensitivity

PubMed Central

Elli, Luca; Branchi, Federica; Tomba, Carolina; Villalta, Danilo; Norsa, Lorenzo; Ferretti, Francesca; Roncoroni, Leda; Bardella, Maria Teresa

2015-01-01

Cereal crops and cereal consumption have had a vital role in Mankind’s history. In the recent years gluten ingestion has been linked with a range of clinical disorders. Gluten-related disorders have gradually emerged as an epidemiologically relevant phenomenon with an estimated global prevalence around 5%. Celiac disease, wheat allergy and non-celiac gluten sensitivity represent different gluten-related disorders. Similar clinical manifestations can be observed in these disorders, yet there are peculiar pathogenetic pathways involved in their development. Celiac disease and wheat allergy have been extensively studied, while non-celiac gluten sensitivity is a relatively novel clinical entity, believed to be closely related to other gastrointestinal functional syndromes. The diagnosis of celiac disease and wheat allergy is based on a combination of findings from the patient’s clinical history and specific tests, including serology and duodenal biopsies in case of celiac disease, or laboratory and functional assays for wheat allergy. On the other hand, non-celiac gluten sensitivity is still mainly a diagnosis of exclusion, in the absence of clear-cut diagnostic criteria. A multimodal pragmatic approach combining findings from the clinical history, symptoms, serological and histological tests is required in order to reach an accurate diagnosis. A thorough knowledge of the differences and overlap in clinical presentation among gluten-related disorders, and between them and other gastrointestinal disorders, will help clinicians in the process of differential diagnosis. PMID:26109797
Diagnosis of gluten related disorders: Celiac disease, wheat allergy and non-celiac gluten sensitivity.

PubMed

Elli, Luca; Branchi, Federica; Tomba, Carolina; Villalta, Danilo; Norsa, Lorenzo; Ferretti, Francesca; Roncoroni, Leda; Bardella, Maria Teresa

2015-06-21

Cereal crops and cereal consumption have had a vital role in Mankind's history. In the recent years gluten ingestion has been linked with a range of clinical disorders. Gluten-related disorders have gradually emerged as an epidemiologically relevant phenomenon with an estimated global prevalence around 5%. Celiac disease, wheat allergy and non-celiac gluten sensitivity represent different gluten-related disorders. Similar clinical manifestations can be observed in these disorders, yet there are peculiar pathogenetic pathways involved in their development. Celiac disease and wheat allergy have been extensively studied, while non-celiac gluten sensitivity is a relatively novel clinical entity, believed to be closely related to other gastrointestinal functional syndromes. The diagnosis of celiac disease and wheat allergy is based on a combination of findings from the patient's clinical history and specific tests, including serology and duodenal biopsies in case of celiac disease, or laboratory and functional assays for wheat allergy. On the other hand, non-celiac gluten sensitivity is still mainly a diagnosis of exclusion, in the absence of clear-cut diagnostic criteria. A multimodal pragmatic approach combining findings from the clinical history, symptoms, serological and histological tests is required in order to reach an accurate diagnosis. A thorough knowledge of the differences and overlap in clinical presentation among gluten-related disorders, and between them and other gastrointestinal disorders, will help clinicians in the process of differential diagnosis.
Aortic stenosis: insights on pathogenesis and clinical implications

PubMed Central

Carità, Patrizia; Coppola, Giuseppe; Novo, Giuseppina; Caccamo, Giuseppa; Guglielmo, Marco; Balasus, Fabio; Novo, Salvatore; Castrovinci, Sebastiano; Moscarelli, Marco; Fattouch, Khalil; Corrado, Egle

2016-01-01

Aortic stenosis (AS) is a common valvular heart disease in the Western populations, with an estimated overall prevalence of 3% in adults over 75 years. To understand its patho-biological processes represents a priority. In elderly patients, AS usually involves trileaflet valves and is referred to as degenerative calcific processes. Scientific evidence suggests the involvement of an active “atherosclerosis-like” pathogenesis in the initiation phase of degenerative AS. To the contrary, the progression could be driven by different forces (such as mechanical stress, genetic factors and interaction between inflammation and calcification). The improved understanding presents potentially new therapeutic targets for preventing and inhibiting the development and progression of the disease. Furthermore, in clinical practice the management of AS patients implies the evaluation of generalized atherosclerotic manifestations (i.e., in the coronary and carotid arteries) even for prognostic reasons. In counselling elderly patients, the risk stratification should address individual frailty beyond the generic risk scores. In these regard, the co-morbidities, and in particular those linked to the global atherosclerotic burden, should be carefully investigated in order to define the risk/benefit ratio for invasive treatment strategies. We present a detailed overview of insights in pathogenesis of AS with possible practical implications. PMID:27582763
Drug Repurposing from an Academic Perspective.

PubMed

Oprea, Tudor I; Bauman, Julie E; Bologa, Cristian G; Buranda, Tione; Chigaev, Alexandre; Edwards, Bruce S; Jarvik, Jonathan W; Gresham, Hattie D; Haynes, Mark K; Hjelle, Brian; Hromas, Robert; Hudson, Laurie; Mackenzie, Debra A; Muller, Carolyn Y; Reed, John C; Simons, Peter C; Smagley, Yelena; Strouse, Juan; Surviladze, Zurab; Thompson, Todd; Ursu, Oleg; Waller, Anna; Wandinger-Ness, Angela; Winter, Stuart S; Wu, Yang; Young, Susan M; Larson, Richard S; Willman, Cheryl; Sklar, Larry A

2011-01-01

Academia and small business research units are poised to play an increasing role in drug discovery, with drug repurposing as one of the major areas of activity. Here we summarize project status for a number of drugs or classes of drugs: raltegravir, cyclobenzaprine, benzbromarone, mometasone furoate, astemizole, R-naproxen, ketorolac, tolfenamic acid, phenothiazines, methylergonovine maleate and beta-adrenergic receptor drugs, respectively. Based on this multi-year, multi-project experience we discuss strengths and weaknesses of academic-based drug repurposing research. Translational, target and disease foci are strategic advantages fostered by close proximity and frequent interactions between basic and clinical scientists, which often result in discovering new modes of action for approved drugs. On the other hand, lack of integration with pharmaceutical sciences and toxicology, lack of appropriate intellectual coverage and issues related to dosing and safety may lead to significant drawbacks. The development of a more streamlined regulatory process world-wide, and the development of pre-competitive knowledge transfer systems such as a global healthcare database focused on regulatory and scientific information for drugs world-wide, are among the ideas proposed to improve the process of academic drug discovery and repurposing, and to overcome the "valley of death" by bridging basic to clinical sciences.
Psychological Flexibility as a Buffer against Caregiver Distress in Families with Psychosis.

PubMed

Jansen, Jens E; Haahr, Ulrik H; Lyse, Hanne-Grethe; Pedersen, Marlene B; Trauelsen, Anne M; Simonsen, Erik

2017-01-01

Background: Research has shown that caregivers of persons with psychosis play an invaluable role in recovery, but unfortunately, often report high levels of distress. While cognitive models of caregiver distress have been well-supported, there is still limited knowledge of the psychological factors involved. Recent advances in cognitive behavioral therapy seem to converge on the importance of acceptance- and mindfulness based processes. Aim: To examine the impact of psychological flexibility on caregiver distress in the early phases of psychosis, while controlling for known predictors of caregiver distress. Method: Within a cross-sectional design, 101 caregivers of 38 persons with first-episode psychosis in a clinical epidemiological sample completed a series of self-report measures. Results: A linear mixed model analysis found that, after controlling for caregiver socio-demographic factors, service user symptoms, drug use and global functioning, psychological flexibility was a significant predictor of caregiver distress. Conclusion: Greater level of psychological flexibility in caregivers, seems to be related to lower levels of caregiver distress. This finding corresponds to studies within a broad range of emotional disorders. There may be important clinical implications in terms of facilitating the process of acceptance through interventions from the 'third-wave' or contextual cognitive behavioral therapies.
Metals and Alzheimer’s Disease: How Far Have We Come in the Clinic?

PubMed Central

Adlard, Paul A.; Bush, Ashley I.

2018-01-01

It is estimated that by the year 2050 there will be more than 1.5 billion people globally over the age of 65 years. Aging is associated with changes to a number of different cellular processes which are driven by a variety of factors that contribute to the characteristic decline in function that is seen across multiple physiological domains/tissues in the elderly (including the brain). Importantly, aging is also the primary risk factor for the development of neurodegenerative disorders such as Alzheimer’s disease. As such, there is an urgent need to provide a greater understanding of both the pathogenesis and treatment of these devastating neurodegenerative disorders. One of the key cellular processes that becomes dysregulated with age and participates both directly and indirectly in age-related dysfunction, is metal homeostasis and the neurochemistry of metalloproteins, the basic science of which has been extensively reviewed in the past. In this review, we will focus on the human clinical intervention trials that have been conducted over approximately the last four decades that have attempted to establish the efficacy of targeting metal ions in the treatment of AD. PMID:29562528
Toward precision manufacturing of immunogene T-cell therapies.

PubMed

Xu, Jun; Melenhorst, J Joseph; Fraietta, Joseph A

2018-05-01

Cancer can be effectively targeted using a patient's own T cells equipped with synthetic receptors, including chimeric antigen receptors (CARs) that redirect and reprogram these lymphocytes to mediate tumor rejection. Over the past two decades, several strategies to manufacture genetically engineered T cells have been proposed, with the goal of generating optimally functional cellular products for adoptive transfer. Based on this work, protocols for manufacturing clinical-grade CAR T cells have been established, but these complex methods have been used to treat only a few hundred individuals. As CAR T-cell therapy progresses into later-phase clinical trials and becomes an option for more patients, a major consideration for academic institutions and industry is developing robust manufacturing processes that will permit scaling-out production of immunogene T-cell therapies in a reproducible and efficient manner. In this review, we will discuss the steps involved in cell processing, the major obstacles surrounding T-cell manufacturing platforms and the approaches for improving cellular product potency. Finally, we will address the challenges of expanding CAR T-cell therapy to a global patient population. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.
Drug Repurposing from an Academic Perspective

PubMed Central

Oprea, Tudor I.; Bauman, Julie E.; Bologa, Cristian G.; Buranda, Tione; Chigaev, Alexandre; Edwards, Bruce S.; Jarvik, Jonathan W.; Gresham, Hattie D.; Haynes, Mark K.; Hjelle, Brian; Hromas, Robert; Hudson, Laurie; Mackenzie, Debra A.; Muller, Carolyn Y.; Reed, John C.; Simons, Peter C.; Smagley, Yelena; Strouse, Juan; Surviladze, Zurab; Thompson, Todd; Ursu, Oleg; Waller, Anna; Wandinger-Ness, Angela; Winter, Stuart S.; Wu, Yang; Young, Susan M.; Larson, Richard S.; Willman, Cheryl; Sklar, Larry A.

2011-01-01

Academia and small business research units are poised to play an increasing role in drug discovery, with drug repurposing as one of the major areas of activity. Here we summarize project status for a number of drugs or classes of drugs: raltegravir, cyclobenzaprine, benzbromarone, mometasone furoate, astemizole, R-naproxen, ketorolac, tolfenamic acid, phenothiazines, methylergonovine maleate and beta-adrenergic receptor drugs, respectively. Based on this multi-year, multi-project experience we discuss strengths and weaknesses of academic-based drug repurposing research. Translational, target and disease foci are strategic advantages fostered by close proximity and frequent interactions between basic and clinical scientists, which often result in discovering new modes of action for approved drugs. On the other hand, lack of integration with pharmaceutical sciences and toxicology, lack of appropriate intellectual coverage and issues related to dosing and safety may lead to significant drawbacks. The development of a more streamlined regulatory process world-wide, and the development of pre-competitive knowledge transfer systems such as a global healthcare database focused on regulatory and scientific information for drugs world-wide, are among the ideas proposed to improve the process of academic drug discovery and repurposing, and to overcome the “valley of death” by bridging basic to clinical sciences. PMID:22368688

Chagas disease drug discovery: toward a new era.

PubMed

Chatelain, Eric

2015-01-01

American trypanosomiasis, or Chagas disease, is the result of infection by the Trypanosoma cruzi parasite. Endemic in Latin America where it is the major cause of death from cardiomyopathy, the impact of the disease is reaching global proportions through migrating populations. New drugs that are safe, efficacious, low cost, and adapted to the field are critically needed. Over the past five years, there has been increased interest in the disease and a surge in activities within various organizations. However, recent clinical trials with azoles, specifically posaconazole and the ravuconazole prodrug E1224, were disappointing, with treatment failure in Chagas patients reaching 70% to 90%, as opposed to 6% to 30% failure for benznidazole-treated patients. The lack of translation from in vitro and in vivo models to the clinic observed for the azoles raises several questions. There is a scientific requirement to review and challenge whether we are indeed using the right tools and decision-making processes to progress compounds forward for the treatment of this disease. New developments in the Chagas field, including new technologies and tools now available, will be discussed, and a redesign of the current screening strategy during the discovery process is proposed. © 2014 Society for Laboratory Automation and Screening.
Immunization in pregnancy clinical research in low- and middle-income countries - Study design, regulatory and safety considerations.

PubMed

Kochhar, Sonali; Bonhoeffer, Jan; Jones, Christine E; Muñoz, Flor M; Honrado, Angel; Bauwens, Jorgen; Sobanjo-Ter Meulen, Ajoke; Hirschfeld, Steven

2017-12-04

Immunization of pregnant women is a promising public health strategy to reduce morbidity and mortality among both the mothers and their infants. Establishing safety and efficacy of vaccines generally uses a hybrid design between a conventional interventional study and an observational study that requires enrolling thousands of study participants to detect an unknown number of uncommon events. Historically, enrollment of pregnant women in clinical research studies encountered many barriers based on risk aversion, lack of knowledge, and regulatory ambiguity. Conducting research enrolling pregnant women in low- and middle-income countries can have additional factors to address such as limited availability of baseline epidemiologic data on disease burden and maternal and neonatal outcomes during and after pregnancy; challenges in recruiting and retaining pregnant women in research studies, variability in applying and interpreting assessment methods, and variability in locally acceptable and available infrastructure. Some measures to address these challenges include adjustment of study design, tailoring recruitment, consent process, retention strategies, operational and logistical processes, and the use of definitions and data collection methods that will align with efforts globally. Copyright © 2017. Published by Elsevier Ltd.
When being narrow minded is a good thing: locally biased people show stronger contextual cueing.

PubMed

Bellaera, Lauren; von Mühlenen, Adrian; Watson, Derrick G

2014-01-01

Repeated contexts allow us to find relevant information more easily. Learning such contexts has been proposed to depend upon either global processing of the repeated contexts, or alternatively processing of the local region surrounding the target information. In this study, we measured the extent to which observers were by default biased to process towards a more global or local level. The findings showed that the ability to use context to help guide their search was strongly related to an observer's local/global processing bias. Locally biased people could use context to help improve their search better than globally biased people. The results suggest that the extent to which context can be used depends crucially on the observer's attentional bias and thus also to factors and influences that can change this bias.
Functional hemispheric asymmetries of global/local processing mirrored by the steady-state visual evoked potential.

PubMed

Martens, Ulla; Hübner, Ronald

2013-03-01

While hemispheric differences in global/local processing have been reported by various studies, it is still under dispute at which processing stage they occur. Primarily, it was assumed that these asymmetries originate from an early perceptual stage. Instead, the content-level binding theory (Hübner & Volberg, 2005) suggests that the hemispheres differ at a later stage at which the stimulus information is bound to its respective level. The present study tested this assumption by means of steady-state evoked potentials (SSVEPs). In particular, we presented hierarchical letters flickering at 12Hz while participants categorised the letters at a pre- cued level (global or local). The information at the two levels could be congruent or incongruent with respect to the required response. Since content-binding is only necessary if there is a response conflict, asymmetric hemispheric processing should be observed only for incongruent stimuli. Indeed, our results show that the cue and congruent stimuli elicited equal SSVEP global/local effects in both hemispheres. In contrast, incongruent stimuli elicited lower SSVEP amplitudes for a local than for a global target level at left posterior electrodes, whereas a reversed pattern was seen at right hemispheric electrodes. These findings provide further evidence for a level-specific hemispheric advantage with respect to content-level binding. Moreover, the fact that the SSVEP is sensitive to these processes offers the possibility to separately track global and local processing by presenting both level contents with different frequencies. Copyright © 2012 Elsevier Inc. All rights reserved.
Kyoto global consensus report on Helicobacter pylori gastritis.

PubMed

Sugano, Kentaro; Tack, Jan; Kuipers, Ernst J; Graham, David Y; El-Omar, Emad M; Miura, Soichiro; Haruma, Ken; Asaka, Masahiro; Uemura, Naomi; Malfertheiner, Peter

2015-09-01

To present results of the Kyoto Global Consensus Meeting, which was convened to develop global consensus on (1) classification of chronic gastritis and duodenitis, (2) clinical distinction of dyspepsia caused by Helicobacter pylori from functional dyspepsia, (3) appropriate diagnostic assessment of gastritis and (4) when, whom and how to treat H. pylori gastritis. Twenty-three clinical questions addressing the above-mentioned four domains were drafted for which expert panels were asked to formulate relevant statements. A Delphi method using an anonymous electronic system was adopted to develop the consensus, the level of which was predefined as ≥80%. Final modifications of clinical questions and consensus were achieved at the face-to-face meeting in Kyoto. All 24 statements for 22 clinical questions after extensive modifications and omission of one clinical question were achieved with a consensus level of >80%. To better organise classification of gastritis and duodenitis based on aetiology, a new classification of gastritis and duodenitis is recommended for the 11th international classification. A new category of H. pylori-associated dyspepsia together with a diagnostic algorithm was proposed. The adoption of grading systems for gastric cancer risk stratification, and modern image-enhancing endoscopy for the diagnosis of gastritis, were recommended. Treatment to eradicate H. pylori infection before preneoplastic changes develop, if feasible, was recommended to minimise the risk of more serious complications of the infection. A global consensus for gastritis was developed for the first time, which will be the basis for an international classification system and for further research on the subject. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Addressing Society's Problems in a Global Studies Class.

ERIC Educational Resources Information Center

Pesce, Louis; And Others

1996-01-01

Describes the adaptation of the Future Problem-Solving Process (FPS) in a global studies class. The process applies state-of-the-art critical thinking and problem solving to unstable areas such as the Middle East and the former Soviet Union. Includes handouts directing the students through the process. (MJP)
A novel pre-processing technique for improving image quality in digital breast tomosynthesis.

PubMed

Kim, Hyeongseok; Lee, Taewon; Hong, Joonpyo; Sabir, Sohail; Lee, Jung-Ryun; Choi, Young Wook; Kim, Hak Hee; Chae, Eun Young; Cho, Seungryong

2017-02-01

Nonlinear pre-reconstruction processing of the projection data in computed tomography (CT) where accurate recovery of the CT numbers is important for diagnosis is usually discouraged, for such a processing would violate the physics of image formation in CT. However, one can devise a pre-processing step to enhance detectability of lesions in digital breast tomosynthesis (DBT) where accurate recovery of the CT numbers is fundamentally impossible due to the incompleteness of the scanned data. Since the detection of lesions such as micro-calcifications and mass in breasts is the purpose of using DBT, it is justified that a technique producing higher detectability of lesions is a virtue. A histogram modification technique was developed in the projection data domain. Histogram of raw projection data was first divided into two parts: One for the breast projection data and the other for background. Background pixel values were set to a single value that represents the boundary between breast and background. After that, both histogram parts were shifted by an appropriate amount of offset and the histogram-modified projection data were log-transformed. Filtered-backprojection (FBP) algorithm was used for image reconstruction of DBT. To evaluate performance of the proposed method, we computed the detectability index for the reconstructed images from clinically acquired data. Typical breast border enhancement artifacts were greatly suppressed and the detectability of calcifications and masses was increased by use of the proposed method. Compared to a global threshold-based post-reconstruction processing technique, the proposed method produced images of higher contrast without invoking additional image artifacts. In this work, we report a novel pre-processing technique that improves detectability of lesions in DBT and has potential advantages over the global threshold-based post-reconstruction processing technique. The proposed method not only increased the lesion detectability but also reduced typical image artifacts pronounced in conventional FBP-based DBT. © 2016 American Association of Physicists in Medicine.
Establishing a program of global initiatives for nursing education.

PubMed

Kulage, Kristine M; Hickey, Kathleen T; Honig, Judy C; Johnson, Mary P; Larson, Elaine L

2014-07-01

In the global nursing community, schools of nursing are increasingly developing initiatives and networks across national boundaries. This article describes the process undertaken at a school of nursing to determine its global health priorities and develop a program of global initiatives for nursing education. A series of meetings were held to determine faculty global activities and gauge interest in designing a 5-year strategic plan for the program. A volunteer Strategic Planning Work-group was convened to formalize a mission, vision, and strategic plan for the program, which were presented to, refined by, and vetted by an advisory board and the faculty at large. We recommend this process to schools committed to developing or expanding a program dedicated to global initiatives and a global perspective in educational planning. Involving stakeholders, building on current strengths, and aligning with mission and vision are essential elements for developing a meaningful program of global initiatives for nursing education. Copyright 2014, SLACK Incorporated.
Alterations to global but not local motion processing in long-term ecstasy (MDMA) users.

PubMed

White, Claire; Brown, John; Edwards, Mark

2014-07-01

Growing evidence indicates that the main psychoactive ingredient in the illegal drug "ecstasy" (methylendioxymethamphetamine) causes reduced activity in the serotonin and gamma-aminobutyric acid (GABA) systems in humans. On the basis of substantial serotonin input to the occipital lobe, recent research investigated visual processing in long-term users and found a larger magnitude of the tilt aftereffect, interpreted to reflect broadened orientation tuning bandwidths. Further research found higher orientation discrimination thresholds and reduced long-range interactions in the primary visual area of ecstasy users. The aim of the present research was to investigate whether serotonin-mediated V1 visual processing deficits in ecstasy users extend to motion processing mechanisms. Forty-five participants (21 controls, 24 drug users) completed two psychophysical studies: A direction discrimination study directly measured local motion processing in V1, while a motion coherence task tested global motion processing in area V5/MT. "Primary" ecstasy users (n = 18), those without substantial polydrug use, had significantly lower global motion thresholds than controls [p = 0.027, Cohen's d = 0.78 (large)], indicating increased sensitivity to global motion stimuli, but no difference in local motion processing (p = 0.365). These results extend on previous research investigating the long-term effects of illicit drugs on visual processing. Two possible explanations are explored: defuse attentional processes may be facilitating spatial pooling of motion signals in users. Alternatively, it may be that a GABA-mediated disruption to V5/MT processing is reducing spatial suppression and therefore improving global motion perception in ecstasy users.
DOE Office of Scientific and Technical Information (OSTI.GOV)

Weiss, K G

The spread of submarines and related technology is an end product of globalization. Globalization is not a new story. By one estimate, our ancestors first crossed out of Africa roughly 80,000 years ago, and began the process that they now call globalization. With the dispersion of people around the world came the development of culture and civilization as well as the spread of ideas, goods, and technology. The process of globalization then is a long-standing one, not an innovation of the late 20th and early 21st centuries. Over the millennia, this process has been an uneven one. Globalization has oftenmore » cuased great disruptions even to the societies that initiated various innovations in culture and civilization, including science and technology. Indeed, many cultures and civilizations have disappeared while some regions failed to advance as rapidly as others, so the process of globalization is not just one of continuing progress. Globalization in the current era seems to be penetrating the most remote corners of the world at a remarkable rate as a result of advances in science and technology, particularly information technology. The diffusion of science and technology is not necessarily a benign development. It could increase the potential for a global military industrial base that may have an adverse affect on world stability in the future. For example, the spread of key military capabilities, like submarines, could still have an impact, especially over the longer term, on the US capability to project power overseas.« less
[Inflammation and obesity (lipoinflammation)].

PubMed

Izaola, Olatz; de Luis, Daniel; Sajoux, Ignacio; Domingo, Joan Carles; Vidal, Montse

2015-06-01

Obesity is a chronic disease with multiple origins. It is a widespread global phenomenon carrying potentially serious complications which requires a multidisciplinary approach due to the significant clinical repercussions and elevated health costs associated with the disease. The most recent evidence indicates that it shares a common characteristic with other prevalent, difficult-to-treat pathologies: chronic, low-grade inflammation which perpetuates the disease and is associated with multiple complications. The current interest in lipoinflammation or chronic inflammation associated with obesity derives from an understanding of the alterations and remodelling that occurs in the adipose tissue, with the participation of multiple factors and elements throughout the process. Recent research highlights the importance of some of these molecules, called pro-resolving mediators, as possible therapeutic targets in the treatment of obesity. This article reviews the evidence published on the mechanisms that regulate the adipose tissue remodelling process and lipoinflammation both in obesity and in the mediators that are directly involved in the appearance and resolution of the inflammatory process. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.
Regulatory guidelines for biosimilars in Malaysia.

PubMed

Abas, Arpah

2011-09-01

The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products. Copyright © 2011. Published by Elsevier Ltd.
RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH.

PubMed

Reichman, Jerome H

2009-01-01

This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as "market exclusivity" and in Europe as "data exclusivity," these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers' undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers' clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers' consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the expense of public health. Although liability rules are better than the status quo, they would not resolve the problem of treating a public good as proprietary. Governments should thus oversee and fund clinical trials as the public good that they are. Clinical tests should be awarded to the most qualified scientists through a competitive process, financed in part with the decrease in drug costs to governmental health care programs and in part with drug developers' contributions, selected to maximize social benefit, and made global via intergovernmental bodies to maximize social return. This would reduce the cost of redundant investigations to the global public health system, lower supply costs to drug consumers, and lower the breakeven point for investment in research to discover new drugs.
Causal implication by rhythmic transcranial magnetic stimulation of alpha frequency in feature-based local vs. global attention.

PubMed

Romei, Vincenzo; Thut, Gregor; Mok, Robert M; Schyns, Philippe G; Driver, Jon

2012-03-01

Although oscillatory activity in the alpha band was traditionally associated with lack of alertness, more recent work has linked it to specific cognitive functions, including visual attention. The emerging method of rhythmic transcranial magnetic stimulation (TMS) allows causal interventional tests for the online impact on performance of TMS administered in short bursts at a particular frequency. TMS bursts at 10 Hz have recently been shown to have an impact on spatial visual attention, but any role in featural attention remains unclear. Here we used rhythmic TMS at 10 Hz to assess the impact on attending to global or local components of a hierarchical Navon-like stimulus (D. Navon (1977) Forest before trees: The precedence of global features in visual perception. Cognit. Psychol., 9, 353), in a paradigm recently used with TMS at other frequencies (V. Romei, J. Driver, P.G. Schyns & G. Thut. (2011) Rhythmic TMS over parietal cortex links distinct brain frequencies to global versus local visual processing. Curr. Biol., 2, 334-337). In separate groups, left or right posterior parietal sites were stimulated at 10 Hz just before presentation of the hierarchical stimulus. Participants had to identify either the local or global component in separate blocks. Right parietal 10 Hz stimulation (vs. sham) significantly impaired global processing without affecting local processing, while left parietal 10 Hz stimulation vs. sham impaired local processing with a minor trend to enhance global processing. These 10 Hz outcomes differed significantly from stimulation at other frequencies (i.e. 5 or 20 Hz) over the same site in other recent work with the same paradigm. These dissociations confirm differential roles of the two hemispheres in local vs. global processing, and reveal a frequency-specific role for stimulation in the alpha band for regulating feature-based visual attention. © 2012 The Authors. European Journal of Neuroscience © 2012 Federation of European Neuroscience Societies and Blackwell Publishing Ltd.
Graduate public health training in healthcare of refugee asylum seekers and clinical human rights: evaluation of an innovative curriculum.

PubMed

Asgary, Ramin

2016-04-01

An innovative curriculum was developed to equip public health students with appropriate attitude and skills to address healthcare of asylum seekers. Implemented in 2005 the curriculum included: (1) didactic sessions covering epidemiology and health sequelae of torture, asylum laws, and approaches to identify survivors' healthcare needs; (2) panel discussions with survivors and advocates; and (3) participating in medico-legal process of asylum seeking. Complementary mixed methods evaluations included pre- and post-curriculum questionnaires, formal curriculum evaluations, final papers and oral presentations. 125 students participated. Students showed improved knowledge regrading sequelae of abuse and survivors' healthcare needs (P < 0.01), improved attitudes towards working with survivors (P < 0.05) and self-efficacy in identifying at-risk populations and addressing healthcare of survivors (P < 0.05). Students reported increased desire to pursue global health and human rights careers. As an advocacy and cultural competency training in public health practice addressing healthcare of refugees domestically, this curriculum was well received and effective, and will also help students better serve other similar populations. Population case-based domestic opportunities to teach global health and health and human rights should be effectively utilized to develop a well-equipped global health corps.
Global neurotrauma research challenges and opportunities.

PubMed

Rubiano, Andrés M; Carney, Nancy; Chesnut, Randall; Puyana, Juan Carlos

2015-11-19

Traumatic injury to the brain or spinal cord is one of the most serious public health problems worldwide. The devastating impact of 'trauma', a term used to define the global burden of disease related to all injuries, is the leading cause of loss of human potential across the globe, especially in low- and middle-income countries. Enormous challenges must be met to significantly advance neurotrauma research around the world, specifically in underserved and austere environments. Neurotrauma research at the global level needs to be contextualized: different regions have their own needs and obstacles. Interventions that are not considered a priority in some regions could be a priority for others. The introduction of inexpensive and innovative interventions, including mobile technologies and e-health applications, focused on policy management improvement are essential and should be applicable to the needs of the local environment. The simple transfer of a clinical question from resource-rich environments to those of low- and middle-income countries that lack sophisticated interventions may not be the best strategy to address these countries' needs. Emphasis on promoting the design of true 'ecological' studies that include the evaluation of human factors in relation to the process of care, analytical descriptions of health systems, and how leadership is best applied in medical communities and society as a whole will become crucial.
Globalization of Nanoengineers' Professional Training: Foreign Experience

ERIC Educational Resources Information Center

Tretko, Vitaliy; Vashkurak, Yuriy

2017-01-01

Conceptual bases of globalization influence onto engineer education in the field of nanoelectronics as well as formation of global skills necessary for life and work in a globalized society have been considered. Modern state of incorporating the global dimension into the process of future nanoelectronics engineers' learning has been analyzed. Key…
The role of global public health strategy in non-profit organisational change at country level: lessons from the joining of Save the Children and Merlin in Myanmar.

PubMed

Campbell, Fiona M; Balabanova, Dina; Howard, Natasha

2018-01-01

The paper presents a case study that critically assesses the role of global strategy 'Public Health on the Frontline 2014-2015' ('the Strategy') in supporting Merlin and Save the Children's organisational change and future programme of the combined organisation in Myanmar. Research was undertaken in 2014 in Myanmar. Twenty-six individual and three group interviews were conducted with stakeholders, and 10 meetings relevant to the country organisational transition process were observed. A conceptual framework was developed to assess the role of the global strategy in supporting the country change process. Several positive aspects of the global strategy were found, as well as critical shortcomings in its support to the organisational change process at country level. The strategy was useful in signalling Save the Children's intention to scale up humanitarian health provision. However, it had only limited influence on the early change process and outcomes in Myanmar. Results highlight several aspects that would enhance the role of a global strategy at country level. Lessons can be applied by organisations undertaking a similar process. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.
Epidemiological and clinical aspects on West Nile virus, a globally emerging pathogen.

PubMed

David, Shoba; Abraham, Asha Mary

2016-08-01

Since the isolation of West Nile virus (WNV) in 1937, in Uganda, it has spread globally, causing significant morbidity and mortality. While birds serve as amplifier hosts, mosquitoes of the Culex genus function as vectors. Humans and horses are dead end hosts. The clinical manifestations of West Nile infection in humans range from asymptomatic illness to West Nile encephalitis. The laboratory offers an array of tests, the preferred method being detection of RNA and serum IgM for WNV, which, if detected, confirms the clinical diagnosis. Although no definitive antiviral therapy and vaccine are available for humans, many approaches are being studied. This article will review the current literature of the natural cycle, geographical distribution, virology, replication cycle, molecular epidemiology, pathogenesis, laboratory diagnosis, clinical manifestations, blood donor screening for WNV, treatment, prevention and vaccines.
Clinical observation, pharmacotherapy and referral on discharge of patients with anxiety disorder in a psychiatric emergency service.

PubMed

Pailhez, Guillem; Majó, Albert; Córcoles, David; Ginés, José M; Arcega, José M; Castaño, Juan; Merino, Ana; Bulbena, Antonio; Pérez, Víctor

2015-01-01

To analyze factors associated with clinical observation, pharmacotherapy and referral on discharge of patients with anxiety disorder (AD) seeking care at a psychiatric emergency unit. A total of 5003 consecutive visits were reviewed over a three-year period at a psychiatric emergency service in a tertiary university hospital. Data collected included sociodemographic and clinical information as well as the Global Assessment of Functioning (GAF) and the Severity Psychiatric Illness (SPI) scale scores. Of all the visits, 992 (19.8%) were diagnosed of AD. Of these, 19.6% required clinical observation and 72.2% were referred to a psychiatrist at discharge. Regression analysis showed that referral to psychiatry was associated with being male, native, psychiatric background, greater severity, lower global functioning, and behavioral disorders. Clinical observation (in a box) was associated with being female, greater severity, and psychotic or behavioral symptoms. Prescription of benzodiazepines was associated with anxiety, no history of addiction, and lower global functioning. Antidepressants were associated with being a native, anxiety with no history of addiction, and lower functioning. Antipsychotics were associated with being native, psychiatric background (not addiction), anxiety, and lower functioning. Behavior, psychiatric background and illness severity were determinants of referral to a specialist. Besides these, psychotic symptoms and non-specific clinical symptoms were determinants of observation. Drug prescription in AD is less frequent if the main complaint is not anxiety and depends more on the level of functioning than on that of severity.

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