scholarly journals Protocol Deviations: A Holistic Approach from Defining to Reporting

Author(s):  
Laura Galuchie ◽  
Catherine Stewart ◽  
Frank Meloni

AbstractImproving interpretation of existing guidelines and management of protocol deviation processes could increase process efficiencies and help reduce noise to support rapid identification of important protocol deviations. Towards this end, TransCelerate identified key principles to build upon and clarify the definition of a protocol deviation and developed a holistic approach to protocol deviation management. The approaches are flexible to suit a variety of indications, study designs, and investigational agents while also supporting consistent application within a study, program or organization.

2007 ◽  
Vol 26 (2) ◽  
pp. 85-97
Author(s):  
Rune Wigblad ◽  
John Lewer ◽  
Magnus Hansson

Both the public and private sectors have since the 1980s relentlessly cut the size of their workforces. The downsizing has regularly been reported to lead to closure of a whole or a part of a corporation or organization. Some studies which have analyzed the closures have reported that remarkable, counterintuitive improvements in labor productivity occurred during the time-period between the closure announcement and the final working day. Testing an elaborated cybernetic model on a Swedish case study, and on an exploratory basis, this paper proposes a holistic approach to generate a better understanding of this phenomenon. The main holistic pattern is a new order where management control is replaced by more “Self-management” on the plant level, and very strong psychological reactions based on feelings of unfairness.


2015 ◽  
Vol 2015 ◽  
pp. 1-12 ◽  
Author(s):  
Mei Zhang ◽  
Danling Wang ◽  
Lequan Min ◽  
Xue Wang

Firstly, this study introduces a definition of generalized stability (GST) in discrete-time nonautonomous chaos system (DNCS), which is an extension for chaos generalized synchronization. Secondly, a constructive theorem of DNCS has been proposed. As an example, a GST DNCS is constructed based on a novel 4-dimensional discrete chaotic map. Numerical simulations show that the dynamic behaviors of this map have chaotic attractor characteristics. As one application, we design a chaotic pseudorandom number generator (CPRNG) based on the GST DNCS. We use the SP800-22 test suite to test the randomness of four 100-key streams consisting of 1,000,000 bits generated by the CPRNG, the RC4 algorithm, the ZUC algorithm, and a 6-dimensional CGS-based CPRNG, respectively. The numerical results show that the randomness performances of the two CPRNGs are promising. In addition, theoretically the key space of the CPRNG is larger than 21116. As another application, this study designs a stream avalanche encryption scheme (SAES) in RGB image encryption. The results show that the GST DNCS is able to generate the avalanche effects which are similar to those generated via ideal CPRNGs.


1996 ◽  
Vol 17 (8) ◽  
pp. 279-283
Author(s):  
Kathi J. Kemper

Over the past 50 years, health care has grown more complex and specialized. Health-care institutions now are staffed with an array of specialist physicians, social workers, psychologists, therapists, and nutritionists as well as general practitioners and nurses. The types of providers outside of the hospital are even more numerous and diverse: physicians; nurses; nurse practitioners; chiropractors; counselors; acupuncturists; herbalists; spiritual healers; and purveyors of nutritional supplements, aromatherapy, crystals, and more. Intent on distinguishing their "products," providers focus on differences, polarizing into distinct camps such as "mainstream or traditional" versus "alternative or unconventional." Although these dichotomies are simple, they also can mislead. The definition of "alternative" is very dependent on the definition "mainstream"; acupuncture may be an alternative in one setting, but it clearly is traditional within Asian communities. Therapies that once were considered unconventional, such as hypnosis and meditation, have moved into many mainstream medical settings. (See Sugarman article "Hypnosis: Teaching Children Self-regulation" in the January 1996 issue of Pediatrics in Review.) The public wants health care that is low-cost, safe, effective, and personalized. Practitioners of "natural" therapies often are viewed as more humanistic and less technological than busy physicians. According to one study, in 1990, alternative medical therapies were used by nearly one third of Americans.1


1996 ◽  
Vol 168 (S30) ◽  
pp. 9-16 ◽  
Author(s):  
Hans-Ulrich Wittchen

Comorbidity has become an increasingly popular theme in psychiatry and clinical psychology, although its heuristic value was recognised long ago. Frequently used in research and practice, no definition of comorbidity is uniformly accepted and it has no comprehensive and coherent theoretical framework. These factors have led to substantial variation in the magnitude of comorbidity across studies. The variability in the definition, assessment and design of comorbidity studies has led to an increasingly complex and confusing picture about the potential value of this concept. The full exploration of mechanisms of comorbidity requires an interdisciplinary approach to investigating nosology, assessment, and underlying models of comorbidity, as well as experimental study designs beyond the scope of clinical and epidemiological studies. A more precise specification of comorbidity patterns might help identify common biochemical and cognitive markers relevant in the aetiology of specific mental disorders as well as comorbid conditions. Critical issues that might help us understand and explain the variability of findings are described.


2019 ◽  
Vol 9 (1) ◽  
pp. 39-55
Author(s):  
Beáta Balogová ◽  
Veronika Kmetóny Gazdová

Abstract Introduction:The authors of this paper base their research on the following assumption: the development of both geragogic education (older adult education) and profession is conditioned by the existence of a study program of geragogy provided by departments of geragogy created at universities (as public institutions of higher education). The fact remains that a qualified training of geragogues is absent in the Slovak conditions. Purpose:When compiling a graduate profile, inclusive of a list of competences that a geragogue should possess, a range of specific local circumstances needs to be taken into consideration. Subsequently, it is necessary to define a position of a geragogue. Geragogue is a professional working in the field of senior education, just like a pedagogue or an adult educator work in their fields. It is also important to identify and accentuate the philosophical and social context in which these professionals are confronted with the demands of today’s society, in a form of a society based on knowledge, questions of the ongoing social changes and defining the meaning of life. Results:The task of creating the department and program of geragogy is formulated as a social demand of the time, debunking the current myth of the crisis of universities. In history, a university was a vital place where the values serving social integration emerged. It was also a practice field for the educators to train so they could spread these values and transform them into social skills. Conclusion:In the conclusion, the authors propose key areas of undergraduate training of geragogues, including the definition of institutional anchoring, with the goal to contribute to ongoing professional discussion and to creation of the department and the program of geragogy.


Author(s):  
Badrane Benlahcene

The purpose of this paper is to present an investigation on the use of the term “civilization” in Muslim intellectual traditions; that is to look for the terms used in various languages used by Muslim peoples to mean civilization. It tries to find out some definition of what we mean by “civilization” as well as whatwe mean by “being civilized” in Islamic intellectual traditions. Therefore, the methodology adopted to achieve the paper's objective is to analyze the various literal and terminological words and terms used to denote civilization in various Muslim languages.The paper finds that in the Muslim scientific and cultural traditions, hadarah, tamaddun or tamadun are the various terms used. However, Ibn Khalduun’s term hadarah is the most appropriate one to express the concept of civilization in its modern sense.It is also clear that the mentioned usages of term “civilization” agree on certain rudimentary elements of civilization, that is, the presence of the city, the order or organization and the sedentary life of its inhabitants.


Ekonomika ◽  
2004 ◽  
Vol 68 ◽  
Author(s):  
Gediminas Ramanauskas

Competitiveness can be defined in a number of ways. We can think of it as of a successful performance of a company or organization; or we may talk about competitiveness in a macro context such as a favourable exchange rate of a national currency. Can we also talk about competitiveness of a nation? What is it and how can it be evaluated?There does not seem to be a common definition of what the international competitiveness of nations is. Some feel that the very notion of international competitiveness of nations is unfair and unacceptable. They argue that the nations themselves do not compete, their enterprises do. For others the notion of international competitiveness of nations is fair. They believe that creating appropriate measures of international competitiveness is central for tracking and understanding the sources of competitiveness of countries.In this paper I classify and compare the measures developed by various authors. I suggest that the studies on the measurement of competitiveness can be classified into five groups:1. Particular sector studies.2. Competitiveness studies at the regional / country level.3. Particular competitiveness indicator studies.4. Competitiveness studies at an international level.5. Cross-country economic policy studies.Since the competitiveness studies serve a different audience and purpose, we cannot discuss which is best without first asking: best at what?


Author(s):  
Roy Rada

The official definition of a healthcare provider is broad. It encompasses institutional providers such as hospitals, nursing facilities, home health agencies, outpatient facilities, clinical laboratories, various licensed healthcare practitioners, and durable medical equipment suppliers. Any individual or organization that is paid to provide healthcare services is a healthcare provider.


Author(s):  
Roberta Guglielmetti Mugion ◽  
Gabriella Arcese ◽  
Martina Toni ◽  
Luca Silvestri

The life cycle sustainability assessment based on Life Cycle Thinking is currently considered the most crucial paradigm that includes three kinds of sustainability variables. Life cycle management (LCM) is the most holistic approach in promoting sustainable value creation, embedding the social, economic, and environmental dimensions as a management tool. LCM is mainly applied in the manufacturing and products chain, whereas it is understudied in the service industry. This chapter proposes the development of the LCM general framework and the definition of indicators for the assessment of sustainability in the urban shared mobility. The research framework has been tested in the transportation sector focusing on car sharing context.


Drones ◽  
2020 ◽  
Vol 4 (3) ◽  
pp. 48
Author(s):  
Amin Majd ◽  
Mohammad Loni ◽  
Golnaz Sahebi ◽  
Masoud Daneshtalab

Interest is growing in the use of autonomous swarms of drones in various mission-physical applications such as surveillance, intelligent monitoring, and rescue operations. Swarm systems should fulfill safety and efficiency constraints in order to guarantee dependable operations. To maximize motion safety, we should design the swarm system in such a way that drones do not collide with each other and/or other objects in the operating environment. On other hand, to ensure that the drones have sufficient resources to complete the required task reliably, we should also achieve efficiency while implementing the mission, by minimizing the travelling distance of the drones. In this paper, we propose a novel integrated approach that maximizes motion safety and efficiency while planning and controlling the operation of the swarm of drones. To achieve this goal, we propose a novel parallel evolutionary-based swarm mission planning algorithm. The evolutionary computing allows us to plan and optimize the routes of the drones at the run-time to maximize safety while minimizing travelling distance as the efficiency objective. In order to fulfill the defined constraints efficiently, our solution promotes a holistic approach that considers the whole design process from the definition of formal requirements through the software development. The results of benchmarking demonstrate that our approach improves the route efficiency by up to 10% route efficiency without any crashes in controlling swarms compared to state-of-the-art solutions.


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