scholarly journals Why and How Should We Integrate Biomarkers into Complex Trials? A Discussion on Paradigms and Clinical Research Strategies

2019 ◽  
Vol 26 (5) ◽  
pp. 343-352
Author(s):  
Frauke Musial ◽  
Scott Mist  ◽  
Sara Warber ◽  
Mary Jo Kreitzer ◽  
Cheryl Ritenbaugh ◽  
...  
Keyword(s):  
Expert Panel ◽  
Complex Interventions ◽  
Research Approach ◽  
Research Strategies ◽  
Disease Condition ◽  
Nonspecific Factors ◽  
Multiple Symptoms ◽  
The Relationship ◽  
Selection Of ◽  
Complementary And Alternative

Background: Research in complementary and alternative medicine (CAM) encounters a variety of challenges, such as potentially synergistic, multimodal, and complex interventions which are often dependent on the relationship between practitioner and patient, on specific settings, and on patients’ individual preferences, expectations, beliefs, and motivations. Moreover, patients seeking CAM care often suffer from chronic disease conditions, and multiple symptoms and/or pathologies. On the other hand, CAM interventions are often challenged as being solely dependent on subjective and nonspecific factors without biologically based mechanisms of action. If we agree that biomarkers as outcomes are important for the understanding of CAM interventions, a hypothesis- and strategy-driven process for the selection of the most appropriate biomarkers is needed. Methods: This paper presents the results of an expert panel on how to integrate biomarkers in whole system research of an interdisciplinary workshop on research methodology in CAM held in November 2012. Results: The following main CAM research challenges were identified: (a) finding appropriate biomarkers, which are able to picture the complex pathophysiological pathways and likewise complex interventions under study; (b) integrating these biomarkers into clinical trials in CAM; and (c) identifying the biomarkers specific to the particular CAM intervention being applied. Conclusion: The paper provides a disease/condition/symptom- and intervention-driven strategy regarding how to identify the outcomes of interest and possible related biomarkers. The research approach presented here allows the selected biomarkers to be grounded in conventional physiology/pathophysiology as well as complementary and alternative concepts, including traditional systems of medicine. The goal is to provide researchers in the field with a framework on how to integrate biomarkers into complex trials.

Posttransplant CMV infection and the role of immunosuppression (Sponsor: Novartis Pharma GmbH, Nürnberg)

2016 ◽  
Vol 04 (01) ◽  
pp. 4-10
Keyword(s):  
Lower Incidence ◽  
Paradigm Shift ◽  
Mtor Inhibitor ◽  
De Novo ◽  
Expert Panel ◽  
Risk Of Infection ◽  
Cmv Infection ◽  
Expert Meeting ◽  
Selection Of

AbstractImmunosuppression permits graft survival after transplantation and consequently a longer and better life. On the other hand, it increases the risk of infection, for instance with cytomegalovirus (CMV). However, the various available immunosuppressive therapies differ in this regard. One of the first clinical trials using de novo everolimus after kidney transplantation [1] already revealed a considerably lower incidence of CMV infection in the everolimus arms than in the mycophenolate mofetil (MMF) arm. This result was repeatedly confirmed in later studies [2–4]. Everolimus is now considered a substance with antiviral properties. This article is based on the expert meeting “Posttransplant CMV infection and the role of immunosuppression”. The expert panel called for a paradigm shift: In a CMV prevention strategy the targeted selection of the immunosuppressive therapy is also a key element. For patients with elevated risk of CMV, mTOR inhibitor-based immunosuppression is advantageous as it is associated with a significantly lower incidence of CMV events.

IMPROVEMENT OF SPRING DURUM WHEAT SELECTION METHODOLOGIES UNDER CLIMATE CHANGE CONDITIONS

1970 ◽  
pp. 33-36
Author(s):  
А. I. Grabovets ◽  
V. P. Kadushkina ◽  
S. А. Kovalenko
Keyword(s):  
Grain Yield ◽  
Durum Wheat ◽  
Correlation Coefficient ◽  
Harvest Index ◽  
Unit Area ◽  
Correlation Coefficients ◽  
Chemical Mutagenesis ◽  
Main Method ◽  
The Relationship ◽  
Selection Of

With the growing aridity of the climate on the Don, it became necessary to improve the methodology for conducting the  breeding of spring durum wheat. The main method of obtaining the source material remains intraspecific step hybridization. Crossings were performed between genetically distant forms, differing in origin and required traits and properties. The use of chemical mutagenesis was a productive way to change the heredity of genotypes in terms of drought tolerance. When breeding for productivity, both in dry years of research and in favorable years, the most objective markers were identified — the size of the aerial mass, the mass of grain per plant, spike, and harvest index. The magnitude of the correlation coefficients between the yield per unit area and the elements of its structure is established. It was most closely associated with them in dry years, while in wet years it decreased. Power the correlation of the characteristics of the pair - the grain yield per square meter - the aboveground biomass averaged r = 0.73, and in dry years it was higher (0.91) than in favorable ones (0.61 - 0.70) , between the harvest and the harvest index - r = 0.81 (on average). In dry years, the correlation coefficient increased to 0.92. Research data confirms the greatest importance of the mass of grain from one ear and the plant in the formation of grain yield per unit area in both dry and wet years. In dry years, the correlation coefficient between yield and grain mass per plant was on average r = 0.80; in favorable years, r = 0.69. The relationship between yield and grain mass from the ear was greater — r = 0.84 and r = 0.82, respectively. Consequently, the breeding significance of the aboveground mass and the productivity of the ear, as a criterion for the selection of the crop, especially increases in the dry years. They were basic in the selection.

Analisa Pemilihan Moda Transportasi Umum Rute Tanjung Karang – Bandara Radin Inten II Dengan Stated Preference dan Uji Crame’s V

2018 ◽  
Vol 2 (2) ◽  
pp. 137
Author(s):  
Muhammad Abi Berkah Nadi
Keyword(s):  
Regression Analysis ◽  
Utility Function ◽  
Stated Preference ◽  
Technical Analysis ◽  
Chi Square ◽  
Time Headway ◽  
Independent Variable ◽  
The Relationship ◽  
Selection Of

Radin Inten II Airport is a national flight in Lampung Province. In this study using the technical analysis stated preference which is the approach by conveying the choice statement in the form of hypotheses to be assessed by the respondent. By using these techniques the researcher can fully control the hypothesized factors. To determine utility function for model forecasting in fulfilling request of traveler is used regression analysis with SPSS program. The analysis results obtained that the passengers of the dominant airport in the selection of modes of cost attributes than on other attributes. From the result of regression analysis, the influence of independent variable to the highest dependent variable is when the five attributes are used together with the R square value of 8.8%. The relationship between cost, time, headway, time acces and service with the selection of modes, the provision that states whether or not there is a decision. The significance of α = 0.05 with chi-square. And the result of Crame's V test average of 0.298 is around the middle, then the relationship is moderate enough.

A Biomarker Combining Imaging and Neuropsychological Assessment for Tracking Early Alzheimer's Disease in Clinical Trials

2018 ◽  
Vol 15 (5) ◽  
pp. 429-442 ◽  
Author(s):  
Nishant Verma ◽  
S. Natasha Beretvas ◽  
Belen Pascual ◽  
Joseph C. Masdeu ◽  
Mia K. Markey ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Cognitive Impairment ◽  
Latent Variable ◽  
Brain Regions ◽  
Disease Assessment ◽  
Latent Variable Analysis ◽  
The Relationship ◽  
Selection Of

Background: Combining optimized cognitive (Alzheimer's Disease Assessment Scale- Cognitive subscale, ADAS-Cog) and atrophy markers of Alzheimer's disease for tracking progression in clinical trials may provide greater sensitivity than currently used methods, which have yielded negative results in multiple recent trials. Furthermore, it is critical to clarify the relationship among the subcomponents yielded by cognitive and imaging testing, to address the symptomatic and anatomical variability of Alzheimer's disease. Method: Using latent variable analysis, we thoroughly investigated the relationship between cognitive impairment, as assessed on the ADAS-Cog, and cerebral atrophy. A biomarker was developed for Alzheimer's clinical trials that combines cognitive and atrophy markers. Results: Atrophy within specific brain regions was found to be closely related with impairment in cognitive domains of memory, language, and praxis. The proposed biomarker showed significantly better sensitivity in tracking progression of cognitive impairment than the ADAS-Cog in simulated trials and a real world problem. The biomarker also improved the selection of MCI patients (78.8±4.9% specificity at 80% sensitivity) that will evolve to Alzheimer's disease for clinical trials. Conclusion: The proposed biomarker provides a boost to the efficacy of clinical trials focused in the mild cognitive impairment (MCI) stage by significantly improving the sensitivity to detect treatment effects and improving the selection of MCI patients that will evolve to Alzheimer’s disease.

Excessive Belching: a Separate Syndrome or Another Symptom of Functional Dyspepsia?

2020 ◽  
Vol 30 (3) ◽  
pp. 55-60 ◽  
Author(s):  
A. A. Sheptulin ◽  
O. A. Storonova
Keyword(s):  
Functional Dyspepsia ◽  
Functional Gastrointestinal Disorders ◽  
High Resolution Manometry ◽  
Published Evidence ◽  
Key Points ◽  
Dyspeptic Symptoms ◽  
The Relationship ◽  
Rome Iv ◽  
Selection Of ◽  
Optimal Treatment Strategy

Aim of review. Interpretation of published evidence on the relationship between the excessive belching syndrome and functional dyspepsia (FD) and their management in patient care.Key points. According to the Rome IV criteria of functional gastrointestinal disorders (FGID), excessive belching in the absence of other dyspeptic symptoms is to be considered a manifestation of the excessive belching syndrome, which can be of gastric or supragastric nature. Combination of high-resolution manometry and impedancemetry allows an accurate diagnosis of belching and selection of optimal treatment strategy. Belching complicated by other symptoms of dyspepsia is to be considered yet another FD symptom according to the Rome IV criteria of FGID. Prokinetics are recommended to relieve belching in such cases.Conclusion. Understanding the relationship between the excessive belching syndrome and FD requires further research.

scholarly journals The Impact of Alkaloid-Producing Epichloë Endophyte on Forage Ryegrass Breeding: A New Zealand Perspective

Toxins ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 158
Author(s):  
Colin Eady
Keyword(s):  
Seed Production ◽  
Health Issues ◽  
Abiotic Stressors ◽  
Livestock Health ◽  
The Right ◽  
The Impact ◽  
The Relationship ◽  
And Storage ◽  
Selection Of ◽  
Epichloë Endophyte

For 30 years, forage ryegrass breeding has known that the germplasm may contain a maternally inherited symbiotic Epichloë endophyte. These endophytes produce a suite of secondary alkaloid compounds, dependent upon strain. Many produce ergot and other alkaloids, which are associated with both insect deterrence and livestock health issues. The levels of alkaloids and other endophyte characteristics are influenced by strain, host germplasm, and environmental conditions. Some strains in the right host germplasm can confer an advantage over biotic and abiotic stressors, thus acting as a maternally inherited desirable ‘trait’. Through seed production, these mutualistic endophytes do not transmit into 100% of the crop seed and are less vigorous than the grass seed itself. This causes stability and longevity issues for seed production and storage should the ‘trait’ be desired in the germplasm. This makes understanding the precise nature of the relationship vitally important to the plant breeder. These Epichloë endophytes cannot be ‘bred’ in the conventional sense, as they are asexual. Instead, the breeder may modulate endophyte characteristics through selection of host germplasm, a sort of breeding by proxy. This article explores, from a forage seed company perspective, the issues that endophyte characteristics and breeding them by proxy have on ryegrass breeding, and outlines the methods used to assess the ‘trait’, and the application of these through the breeding, production, and deployment processes. Finally, this article investigates opportunities for enhancing the utilisation of alkaloid-producing endophytes within pastures, with a focus on balancing alkaloid levels to further enhance pest deterrence and improving livestock outcomes.

Selection of Materials and Sensors for Health Monitoring of Composite Structures

2003 ◽  
Vol 785 ◽  
Author(s):  
Seth S. Kessler ◽  
S. Mark Spearing
Keyword(s):  
Health Monitoring ◽  
Lamb Wave ◽  
Composite Structures ◽  
Structural Damage ◽  
Performance Metrics ◽  
Full Range ◽  
Transportation Systems ◽  
Health Monitoring Systems ◽  
The Relationship ◽  
Selection Of

ABSTRACTEmbedded structural health monitoring systems are envisioned to be an important component of future transportation systems. One of the key challenges in designing an SHM system is the choice of sensors, and a sensor layout, which can detect unambiguously relevant structural damage. This paper focuses on the relationship between sensors, the materials of which they are made, and their ability to detect structural damage. Sensor selection maps have been produced which plot the capabilities of the full range of available sensor types vs. the key performance metrics (power consumption, resolution, range, sensor size, coverage). This exercise resulted in the identification of piezoceramic Lamb wave transducers as the sensor of choice. Experimental results are presented for the detailed selection of piezoceramic materials to be used as Lamb wave transducers.

scholarly journals Dyads in Dementia Care: An International Perspective on Research Challenges and Opportunities

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 757-757
Author(s):  
Marie Boltz ◽  
Karin Wolf-Ostermann ◽  
Katie Maslow
Keyword(s):  
Daily Practice ◽  
Well Being ◽  
International Perspective ◽  
Dementia Care ◽  
Research Approach ◽  
Ethical Challenges ◽  
Research Strategies ◽  
Policy And Practice ◽  
Challenges And Opportunities ◽  
Informal Carers

Abstract Dementia poses a societal challenge that is life-changing not only for persons with dementia (PWD) but also for family members and friends (informal carers) directly involved in the care arrangement. Informal carers (IC) have typically poorer outcomes in terms of well-being, quality of life (QoL), health status, and use of health care resources. Dyads of PWD and IC living with dementia are characterized by strong reciprocal relationships and complex living contexts. Therefore, research should investigate home based dementia caregiving from a dyadic perspective to yield interventions that support the PWD, the IC, and the unit as a whole. However, it is an ongoing challenge to investigate dyadic needs and preferences in daily practice and develop effective interventions. Challenges are related to incomplete understanding of dyadic characteristics, attitudes and beliefs within the dyad, as well as how to adapt research approach to engage and retain the dyad in research. This international symposium will therefore address these issues. The first presentation will describe a typology of dementia care dyad characteristics and needs in Germany. The second presentation will examine the challenges and opportunities associated with recruiting and retaining dementia dyads. The third presentation will explore ethical challenges posed in communication with dyads and possible solutions for the researcher. The final presentation reports on the Meeting Centre Support Program as an example of an effective psychosocial intervention employing research strategies that transcend cultural barriers. Our discussant, Katie Maslow, will synthesize the presentations and lead a discussion of future directions for policy and practice.

Dance and Ethnicity

2016 ◽  
Author(s):  
Anthony Shay ◽  
Barbara Sellers-Young
Keyword(s):  
Cultural Studies ◽  
Ethnic Groups ◽  
Identity Construction ◽  
Research Approach ◽  
Transnational Politics ◽  
Dance Studies ◽  
Ethnic Category ◽  
The Creation ◽  
The Relationship ◽  
Active Contributor

Ethnic groups have been defined as people who share a common ethos based on ancestry, nation, language and other identity markers. This volume brings scholars from across the globe that have incorporated perspectives from critical and cultural studies in an investigation of what it means to define oneself in an ethnic category and how this category is performed and represented as an ethnicity. The essays in this volume engage the four themes of identity construction, local and transnational politics, appropriation and related exotification, and resistance that are part of the ongoing discourse in the relationship between dance and ethnicity. Cumulatively, the essays in their research approach and methodology document the change that has taken place in dance studies from the ethnic as an easily identified category based on biology and geography to ethnicity as a fluid concept and dance as an active contributor to the creation and negotiation of it.

The relationship between MNCs’ strategies and executive staffing

2017 ◽  
Vol 25 (2) ◽  
pp. 233-250 ◽  
Author(s):  
Sangeetha Lakshman ◽  
C. Lakshman ◽  
Christophe Estay
Keyword(s):  
International Business ◽  
Business Strategy ◽  
Global Strategy ◽  
Business Strategies ◽  
Future Research ◽  
Research Approach ◽  
Global Integration ◽  
Content Type ◽  
Managerial Implications ◽  
The Relationship

Purpose The purpose of this paper is to examine the relationship of business strategies with executive staffing of multinational companies (MNCs). Design/methodology/approach Based on in-depth interviews conducted with top executives of 22 MNCs’, the authors identify important connections between international business strategies and staffing orientation. The authors used the qualitative research approach of building theory from interviews; thus, creating theoretical propositions from empirical evidence. Findings The authors find that when the pressure for global integration is high, MNCs use more parent-country national (PCNs) (ethnocentric staffing) as against the use of host-country managers (HCNs) (polycentric staffing) when this pressure is low. Additionally, MNCs using a global strategy are more likely to use an ethnocentric staffing approach, those using a multi-domestic strategy use a polycentric approach and firms using transnational strategy adopt a mix of ethnocentric and polycentric approaches. Research limitations/implications Although the authors derive theoretical patterns based on rich qualitative data, their sample is relatively small and comprises mostly of French MNCs. Generalizability to a broader context is limited. However, the authors’ findings have critical implications for future research. Practical implications The authors’ findings provide critical managerial implications for MNCs in matching their HR strategies with business strategies. These are important for effective strategy implementation. Originality/value Although MNC staffing orientations have been studied for a long time, their relationship to international business strategies is still not clearly understood. The authors contribute to the literature by investigating the relationship between MNCs’ business strategy types with staffing orientations.

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