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Clinical Outcome Event Adjudication in a 10-Year Prospective Study of Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B

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Journal of Clinical and Translational Hepatology 2020年第4期8卷 377-384页

作者： Joseph K Lim Alex Y Chang Atif Zaman Paul martin Conrado m Fernandez-Rodriguez mete Korkmaz Simona Rossi james m ford Tamara Noonan Elizabeth Cooney Victor Navarro Luis Colombato Yale University School of medicine New HavenCTUSA Johns Hopkins School of medicine BaltimoreMDUSA and Johns Hopkins SingaporeSingapore Oregon Health&Science University PortlandORUSA University of miami miller School of medicine MiamiFLUSA Hospital Universitario Fundación Alcorcón MadridSpain OSF Saint Anthony Center for Cancer Care RockfordILUSA Einstein Healthcare Network PhiladelphiaPAUSA Stanford University School of medicine StanfordCAUSA Bristol-myers Squibb WallingfordCTUSA Hospital Británico UCA School of MedicineBuenos AiresArgentina

Background and Aims:In the REALm (Randomized, Obser-vational Study of Entecavir to Assess Long-Term Outcomes Associated with Nucleoside/Nucleotide monotherapy for Pa-tients with Chronic HBV Infection) study, 12,378 patients with chronic hepatitis B virus (HBV) infection received up to 10 years of randomized therapy with entecavir or another HBV nucleos(t)ide analogue. monitored clinical outcome events (COEs) included malignant neoplasms, HBV disease progres-sion events, and deaths. An external event adjudication com-mittee (EAC) was convened to provide real-time review of reported COEs to optimize data quality, and minimize poten-tial adverse effects of the large cohort, interdisciplinary out-come assessments, geographic scope, and long duration. methods:The EAC comprised an international group of hep-atologists and oncologists with expertise in diagnosis of tar-geted COEs. The EAC reviewed and adjudicated COEs according to prospectively defined diagnostic criteria cap-tured in the EAC charter. Operational processes, including da-ta collection and query procedures, were implemented to optimize efficiency of data recovery to maximize capture of adjudicated COEs, the primary study outcome measure. Results: A total of 1724 COEs were reported and 1465 of these events were adjudicated by the EAC as reported by the investigators (85.0% overall concordance). Concordance by COE type varied: deaths, 99.6%;hepatocellular carcino-ma (HCC), 83.3%;non-HCC malignancies, 88.0%;non-HCC HBV disease progression, 68.2%. Reasons for lack of con-cordance were most commonly lack of adequate supporting data to support an adjudicated diagnosis or evidence that the event pre-dated the study. Conclusions: The REALm EAC performed a critical role in ensuring data quality and consis-tency;EAC performance was facilitated by well-defined diag-nostic criteria, effective data capture, and efficient operational processes. Trial registration: *** NCT00388674.

关键词： Hepatitis B Antiviral therapy Clinical outcomes Event adjudication Liver cirrhosis

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Toward the Fourth Industrial Revolution on Real-Time Customization

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Journal of Systems Science and Systems Engineering 2020年第2期29卷 127-142页

作者： james m.Tien College of Engineering University of MiamiCoral GablesFlorida 33146USA

The outputs of a national economy can be partitioned into three sets of products:tangible goods(due to manufacturing,construction,extraction and agriculture),intangible services(due to an act of useful effort),and an integration of services and goods or,as initially defined by Tien(2012),***,these products can also be considered in terms of their relation to the first three Industrial Revolutions:the First Industrial Revolution(circa 1800)was primarily focused on the production of goods;the Second Industrial Revolution(circa 1900)was primarily focused on the mass production of goods;and the Third Industrial Revolution(circa 2000)has been primarily focused on the mass customization of goods,services or *** this follow-up paper,the Third Industrial Revolution of mass customization continues to accelerate in its evolution and,in many respects,is subsuming the earlier Industrial Revolutions of production and mass *** importantly,with the advent of real-time decision making,artificial intelligence,Internet of Things,mobile networks,and other advanced digital technologies,customization has been extensively enabled,thereby advancing mass customization into a Fourth Industrial Revolution of real-time ***,the moral,ethical,security and employment problems associated with both mass and real-time customization must be carefully assessed and mitigated,especially in regard to unintended *** ahead and with the advance of artificial general intelligence,this Fourth Industrial Revolution could be forthcoming in about the middle of the 21st Century;it would allow for multiple activities to be simultaneously tackled in real-time and in a customized manner.

关键词： Industrial revolutions big data goods services servgoods connected production mass customization real-time decision making Internet of Things artificial intelligence general

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THE NEXT INDUSTRIAL REVOLUTION:INTEGRATED SERVICES AND GOODS

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Journal of Systems Science and Systems Engineering 2012年第3期21卷 257-296页

作者： james m.TIEN College of Engineering University of MiamiCoral GablesFlorida 33146USA

The outputs or products of an economy can be divided into services products ana gooas products （due to manufacturing, construction, agriculture and mining）. To date, the services and goods products have, for the most part, been separately mass produced. However, in contrast to the first and second industrial revolutions which respectively focused on the development and the mass production of goods, the next - or third - industrial revolution is focused on the integration of services and/or goods; it is beginning in this second decade of the 21st Century. The Third Industrial Revolution （TIR） is based on the confluence of three major technological enablers （i.e., big data analytics, adaptive services and digital manufacturing）; they underpin the integration or mass customization of services and/or goods. As detailed in an earlier paper, we regard mass customization as the simultaneous and real-time management of supply and demand chains, based on a taxonomy that can be defined in terms of its underpinning component and management foci. The benefits of real-time mass customization cannot be over-stated as goods and services become indistinguishable and are co-produced - as ＂servgoods＂ - in real-time, resulting in an overwhelming economic advantage to the industrialized countries where the consuming customers are at the same time the co-producing producers.

关键词： Big data decision analytics goods adaptive services digital manufacturing value chain supply chain demand chain mass production mass customization industrial revolution

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Detecting white matter alterations in multiple sclerosis using advanced diffusion magnetic resonance imaging

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Neural Regeneration Research 2019年第1期14卷 114-123页

作者： Sourajit m.mustafi Jaroslaw Harezlak Chandana Kodiweera Jennifer S.Randolph james C.ford Heather A.Wishart Yu-Chien Wu Department of Radiology and Imaging Sciences Indiana University School of Medicine Department of Epidemiology and Biostatistics School of Public Health Indiana University Department of Psychological and Brain Sciences and Dartmouth Brain Imaging Center Dartmouth College Department of Psychiatry Geisel School of Medicine at Dartmouth

multiple sclerosis is a neurodegenerative and inflammatory disease, a hallmark of which is demyelinating lesions in the white matter. We hypothesized that alterations in white matter microstructures can be non-invasively characterized by advanced diffusion magnetic resonance imaging. Seven diffusion metrics were extracted from hybrid diffusion imaging acquisitions via classic diffusion tensor imaging, neurite orientation dispersion and density imaging, and q-space imaging. We investigated the sensitivity of the diffusion metrics in 36 sets of regions of interest in the brain white matter of six female patients(age 52.8 ± 4.3 years) with multiple sclerosis. Each region of interest set included a conventional T2-defined lesion, a matched perilesion area, and normal-appearing white matter. Six patients with multiple sclerosis(n = 5) or clinically isolated syndrome(n = 1) at a mild to moderate disability level were recruited. The patients exhibited microstructural alterations from normal-appearing white matter transitioning to perilesion areas and lesions, consistent with decreased tissue restriction, decreased axonal density, and increased classic diffusion tensor imaging diffusivity. The findings suggest that diffusion compartment modeling and q-spa ce analysis appeared to be sensitive for detecting subtle microstructural alterations between perilesion areas and normal-appearing white matter.

关键词： multiple sclerosis hybrid diffusion imaging NODDI diffusion tensor imaging q-space imaging

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ON INTEGRATION AND ADAPTATION IN COmPLEX SERVICE SYSTEmS

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Journal of Systems Science and Systems Engineering 2008年第4期17卷 385-415页

作者： james m.TIEN College of Engineering University of miami Coral GablesFloridaUSA

The services sector employs a large and growing proportion of workers in the industrialized nations, and it is increasingly dependent on information and communication technologies. While the interdependences, similarities and complementarities of manufacturing and services are significant, there are considerable differences between goods and services, including the shift in focus from mass production to mass customization （whereby a service is produced and delivered in response to a customer＇s stated or imputed needs）. In general, services can be considered to be knowledge-intensive agents or components which work together as providers and consumers to create or co-produce value. Like manufacturing systems, an efficient service system must be an integrated system of systems, leading to greater connectivity and interdependence. Integration must occur over the physical, temporal, organizational and functional dimensions, and must include methods concerned with the component, the management, and the system. moreover, an effective service system must also be an adaptable system, leading to greater value and responsiveness. Adaptation must occur over the dimensions of monitoring, feedback, cybernetics and learning, and must include methods concerned with space, time, and system. In sum, service systems are indeed complex, especially due to the uncertainties associated with the human-centered aspects of such systems. moreover, the system complexities can only be dealt with methods that enhance system integration and adaptation. The paper concludes with several insights, including a plea to shift the current misplaced focus on developing a science or discipline for services to further developing a systems engineering approach to services, an approach based on the integration and adaptation of a host of sciences or disciplines （e.g., physics, mathematics, statistics, psychology, sociology, etc.）. In fact, what is required is a services-related transdisciplinary - beyond a s

关键词： Services service system system components system integration system adaptation system of systems decision informatics real-time decision making

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BIG DATA:UNLEASHING INFORmATION

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Journal of Systems Science and Systems Engineering 2013年第2期22卷 127-151页

作者： james m.TIEN College of Engineering University of Miami

At present, it is projected that about 4 zettabytes （or 10^＊＊21 bytes） of digital data are being generated per year by everything from underground physics experiments to retail transactions to security cameras to global positioning systems. In the U. S., major research programs are being funded to deal with big data in all five sectors （i.e., services, manufacturing, construction, agriculture and mining） of the economy. Big Data is a term applied to data sets whose size is beyond the ability of available tools to undertake their acquisition, access, analytics and/or application in a reasonable amount of time. Whereas Tien （2003） forewarned about the data rich, information poor （DRIP） problems that have been pervasive since the advent of large-scale data collections or warehouses, the DRIP conundrum has been somewhat mitigated by the Big Data approach which has unleashed information in a manner that can support informed - yet, not necessarily defensible or valid - decisions or choices. Thus, by somewhat overcoming data quality issues with data quantity, data access restrictions with on-demand cloud computing, causative analysis with correlative data analytics, and model-driven with evidence-driven applications, appropriate actions can be undertaken with the obtained information. New acquisition, access, analytics and application technologies are being developed to further Big Data as it is being employed to help resolve the 14 grand challenges （identified by the National Academy of Engineering in 2008）, underpin the 10 breakthrough technologies （compiled by the massachusetts Institute of Technology in 2013） and support the Third Industrial Revolution of mass customization.

关键词： Big data data acquisition data access data analytics data application decision informatics products processes adaptive services digital manufacturing mass customization third industrial revolution

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VIEWING URBAN DISRUPTIONS FROm A DECISION INFORmATICS PERSPECTIVE

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Journal of Systems Science and Systems Engineering 2005年第3期14卷 257-288页

作者： james m. TIEN Rensselaer Polytechnic Institute Troy New York USA

Urban infrastructures are the focus of terrorist acts because, quite simply, they produce the most visible impact, if not casualties. While terrorist acts are the most insidious and onerous of all disruptions, it is obvious that there are many similarities to the way one should deal with these willful acts and those caused by natural and accidental incidents that have also resulted in adverse and severe consequences. However, there is one major and critical difference between terrorist acts and the other types of disruptions： the terrorist acts are willful - and therefore also adaptive, if not coordinated. One must counter these acts with the same, if not more sophisticated, willful, adaptive and informed approach. Real-time, information-based decision making - which Tien （2003） has called the decision informatics paradigm - is the approach advanced herein to help make the right decisions at the various stages of a disruption. It is focused on decisions and based on multiple data sources, data fusion and analysis methods, timely information, stochastic decision models and a systems engineering outlook; moreover, it is multidisciplinary, evolutionary and systemic in practice. The approach provides a consistent way to address real-time emergency issues, including those concerned with the preparation for a major disruption, the prediction of such a disruption, the prevention or mitigation of the disruption, the detection of the disruption, the response to the disruption, and the recovery steps that are necessary to adequately, if not fully, recuperate from the disruption. The efforts of the U. S. Department of Homeland Security and its academically-based Homeland Security Centers of Excellence are considered within the proposed types, stages and decisions framework.

关键词： Data fusion data analysis adaptive algorithms decision modeling systems engineering

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THE SPUTNIK OF SERVGOODS： AUTONOmOUS VEHICLES

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Journal of Systems Science and Systems Engineering 2017年第2期26卷 133-162页

作者： james m. Tien College of Engineering University of Miami Coral Gables Florida 33146 USA

In an earlier paper （Tien 2015）, the author defmed the concept of a servgood, which can be thought of as a physical good or product enveloped by a services-oriented layer that makes the good smarter or more adaptable and customizable for a particular use. Adding another layer of physical sensors could then enhance its smartness and intelligence, especially if it were to be connected with each other or with other servgoods through the Internet of Things. Such sensed servgoods are becoming the products of the future. Indeed, autonomous vehicles can be considered the exemplar servgoods of the future; it is about decision informatics and embraces the advanced technologies of sensing （i.e., Big Data）, processing （i.e., real-time analytics）, reacting （i.e., real-time decision-making）, and learning （i.e., deep learning）. Since autonomous vehicles constitute a huge quality-of-life disruption, it is also critical to consider its policy impact on privacy and security, regulations and standards, and liability and insurance. Finally, just as the Soviet Union inaugurated the space age on October 4, 1957, with the launch of Sputnik, the first man-made object to orbit the Earth, the U. S. has inaugurated an age of automata or autonomous vehicles that can be considered to be the U. S. Sputnik of servgoods, with the full support of the U. S. government, the U. S. auto industry, the U. S. electronic industry, and the U.S. higher educational enterprise.

关键词： Autonomous vehicles goods services servgoods sensors Internet of Things decisioninformatics Big Data real-time analytics cloud computing deep learning privacy security regulations,standards liability insurance Sputnik

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INTERNET OF CONNECTED SERVGOODS:CONSIDERATIONS,CONSEQUENCES AND CONCERNS

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Journal of Systems Science and Systems Engineering 2015年第2期24卷 130-167页

作者： james m.Tien College of Engineering University of Miami

In an earlier paper （Tien 2012）, the author augurs that, in contrast to the first and second industrial revolutions which respectively focused on the development and the mass production of goods, the next - or third - industrial revolution is focused on the integration of services and/or goods; it began in this second decade of the 21st Century. The Third Industrial Revolution （TIR） is underpinned by the integration or mass customization of services and/or goods. The benefits of real-time mass customization cannot be over-stated as goods and services become indistinguishable and are co-produced as ＂ServGoods＂, resulting in an overwhelming economic advantage to the industrialized countries where the consuming customers are at the same time the co-producing producers. Adding sensors to these ServGoods and letting them connect or communicate among themselves or with other ServGoods can result in an Intemet of Things （i.e., connected ServGoods）. A number of considerations, consequences and concerns relating to such an Intemet of Connected ServGoods are discussed herein.

关键词： Goods services ServGoods sensors Big Data decision analytics adaptive services digital manufacturing value chain supply chain demand chain mass production mass customization industrial revolution Intemet of Things

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mANUFACTURING AND SERVICES:FROm mASS PRODUCTION TO mASS CUSTOmIZATION

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Journal of Systems Science and Systems Engineering 2011年第2期20卷 129-154页

作者： james m.TIEN College of Engineering University of MiamiCoral Gables

manufacturing and services constitute two of the five sectors of every country＇s economy;depending on the maturity of the economy,they are-in terms of employment-typically the two largest *** outputs or products of an economy can also be divided into goods products（due to manufacturing,construction,agriculture and mining） and services *** date,the goods and services products have,for the most part,been mass produced;it is the premise of this paper that recent technological advances-including flexible manufacturing,cloud computing,nanotechnology and smart sensing-can better enable the transformation from mass production to mass *** regard mass customization as the simultaneous and real time management of supply and demand chains,based on a taxonomy that can be defined in terms of its underpinning component and management *** a components perspective,we first consider the value chain of supplier,manufacturer,assembler,retailer,and customer,and then develop a consistent set of definitions for supply and demand chains based on the location of the customer order penetration *** a management perspective,we classify the methods that are employed in the management of these chains,based on whether supply and/or demand are flexible or ***,our management taxonomy highlights a very critical research area at which both supply and demand are flexible,thus *** management of supply and demand chains sets the stage for mass customization which is concerned with meeting the needs of an individualized customer *** and real time management of supply and demand chains set the stage for real time mass customization（e.g.,wherein a tailor first laser scans an individual＇s upper torso and then delivers a uniquely fitted jacket within a reasonable period,while the individual is waiting）.The benefits of real time mass customization cannot be over-stated as goods and services become indistinguishable

关键词： Value chain supply chain demand chain taxonomy real time management mass production mass customization manufacturing goods services

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