What disease is and how it affects humans is the focus of this primer. Designed to cover the basics of communicable and non-communicable diseases, the book provides a framework for understanding the major health problems in our society. Hurster uses the Biological Laws of Disease to frame each discussion and to demonstrate how these laws relate to the prepathogenesis and pathogenesis stages of the natural history of any disease. Considerable attention is given to the roles of the individual, the community, and the government in bringing about behavior change with respect to disease prevention, detection, control, and management.

*A focus on normal theory linking average power, expected power, predictive power, assurance, conditional Bayesian power and Bayesian power. *Extensions of the concepts to binomial, and time-to-event outcomes and non-inferiority trials *An investigation into the upper bound on average power, assurance and Bayesian power based on the prior probability of a positive treatment effect *Application of assurance to a series of trials in a development program and an introduction of the assurance of an individual trial conditional on the positive outcome of an earlier trial in the program, or to the successful outcome of an interim analysis *Prior distribution of power and sample size *Extension of the basic approach to proof-of-concept trials with dual success criteria *Investigation of the connection between conditional and predictive power at an interim analysis and power and assurance *Introduction of the idea of surety in sample sizing of clinical trials based on the width of the confidence intervals for the treatment effect, and an unconditional version.

Cover simple modelling approaches as well as full Monte Carlo simulation of x-ray tubes Bremsstrahlung and characteristic contributions to the spectrum are discussed in detail Learning is supported by free open-source software and an online repository of code.

Comparing and Contrasting the Impact of the COVID-19 Pandemic in the European Union challenges the use of uncontextualised comparisons of COVID-19 cases and deaths in member states during the period when Europe was the epicentre of the pandemic. This timely study looks behind the headlines and the statistics to demonstrate the value for knowledge exchange and policy learning of comparisons that are founded on an in-depth understanding of key socio-demographic and public health indicators within their policy settings. The book adopts innovative, integrated, multi-disciplinary international perspectives to track and assess a fast-moving topical subject in an accessible format. It offers a template for analysing policy responses to the COVID-19 pandemic and for using evidence-based comparisons to inform and support policy development.

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.

Ophthalmic Epidemiology: Current Concepts to Digital Strategies provides a comprehensive guide to graduate students, ophthalmologists, and researchers in ophthalmic epidemiology. It covers recently developed new methodologies, technologies and resources in ocular epidemiological research, such as telemedicine, disease registries, EMR, bio-banks and omics. This book also summarizes recent epidemiological findings and provides up-to-date data on ocular diseases. Furthermore, it introduces and discusses the uses of epidemiology in the evaluation of health services and population screening programs and reviews the application of epidemiology in intervention trials in the communities. Key Features Comprehensive guide to the epidemiology of common eye diseases. Provides updates on the prevalence and risk factors of eye diseases. Outlines how epidemiological techniques can be utilized to evaluate ophthalmic health services and programs.

This volume presents the procedings of an "Advanced Research Workshop," held under the auspices of the NATO International Scientific Exchange Programme, on the Environmental and Non-environmental Determinants of the East-West Life Expectancy Gap in Europe. The workshop brought together individuals from Eastern and Western Europe and North America who had a common interest in understanding the evolution of the relative declines in life expectancy in Central and Eastern Europe, compared to the West, over the past 30 years. Between 1989 and 1993, I carried out a series of investigations into the effects of environmental pollution on human health in Central and Eastern Europe, at first, under the auspices of the World Bank, and later, under a broader multilateral, multi-agency arrangement known as the "Environment for Europe" Process. These investigations provided unparalleled access to environmental health data from the region, and offered a glimpse of what the contribution of pollution to health status was, and what it was not. At the same time, the Program in Population Health of the Canadian Institute for Advanced Research (CIAR) and the International Centre for Health and Society (ICHS) at University College, London, were embarking upon multi-disciplinary inquiries into the broad determinants of health in modern societies. The work of the CIAR provided a framework for conceptualizing the East-West life expectancy gap and its potential determinants; the work of the ICHS provided specific insights into the relative contributions of these determinants.

This ambitious reference surveys worldwide efforts at controlling the spread of tuberculosis, with special emphasis on the developing world. Case studies from China, Pakistan, Nigeria, Indonesia, and other frontline countries demonstrate a wealth of information on clinical, cultural, socioeconomic, and other relevant factors. This compilation provides a valuable resource for creating successful intervention and prevention strategies. State-of-the-science snapshots pinpoint where short- and long-term initiatives stand today, from early detection and vaccination programs to new genetic technologies and drug therapies. This diverse group of perspectives and approaches offers innovative paths toward control and realistic odds for containing the threat, especially in the face of current co-epidemics and new drug-resistant strains. Among the topics in the Handbook: Diagnosis of tuberculosis: current pipeline, unmet needs, and new developments Concurrence of tuberculosis and other major diseases The tuberculosis outbreak response, investigation, and control The promise of new TB vaccines DNA fingerprinting of Mycobacterium tuberculosis: a rich source of fundamental and daily applicable knowledge Global tuberculosis surveillance The Handbook of Global Tuberculosis Control is urgent reading for leadership and staff of non-governmental organizations, government agencies, academic institutions, research centers, hospitals, and potentially businesses with interests in tuberculosis control. Additionally, the book's focus on TB in developing countries will attract a wider audience of practitioners, particularly those working in the broader fields of global public health, epidemiology, international development, and the socioeconomics of infectious diseases.

This book looks at the institutional and governance issues faced by India during the first and second wave of the COVID-19 pandemic and its adverse impact on the vulnerable sectors and groups. The book is split into four parts, with preceding chapters informing later ones. Part One outlines the approach of the study, in particular their examination of policy responses and the effect of the pandemic. Part Two delves into the governance challenges in containing the pandemic while giving the theoretical rationale for institutional responses. Part Three looks at how the pandemic affected economically vulnerable households, workers, and small industries. The effect of pandemic on the informal sector is also detailed. Lastly, Part Four examines the impacts and responses of Indian public infrastructure and services to the pandemic, in particular the impact of the COVID-19 pandemic on health care and schooling. It also explores the challenges caused by infrastructure inadequacies in Indian cities. The book closes by looking at how businesses in the private sector have responded to the COVID-19 pandemic, with a focus on Corporate Social Responsibility. The book will be a useful reference to researchers, policymakers, and practitioners who are interested in institutions and development, especially in the context of India.

Social psychiatry is a multidisciplinary field analyzing mechanisms of mental health issues comprehensively to contribute to society using the findings. Those findings include biological, psychological, and social aspects and they are based on psychiatry and connected with a wide variety of academic fields, including psychology, sociology, law, economics, and religious studies. Epidemiological research in psychiatry is a field of study in patients with psychiatric disorder attempting to investigate causes, to develop clinical applications of the results, and to determine applications to health services plans for individuals and/or communities. They are both foundation for understanding biopsychosocial view in psychiatry but not many comprehensive volumes covering the topic were not available until now. This book is thus a unique, comprehensive reference with evidence-based approach to provide concise summary of researches for such as schizophrenia, affective disorders, psychiatric disorders in the general practice setting, and disaster psychiatry, especially for the case of atomic bomb diseases. The studies were mostly carried out in the region of Nagasaki, the prefecture experienced a nuclear attack at the time of World War . Psychiatric findings in mental health problems among atomic bomb survivors and sufferers in Nagasaki has been established and Nagasaki is the only area that fulfills the conditions of the subject of the study of psychiatric epidemiology and social psychiatry which is going to be described in this book. This book provides a valuable resource not only for physicians and researchers in the field of psychiatry and mental health but for people who work for mental health welfare department."

Climatic change plays an integral part in planetary health and is amongst the most important global environmental aspect that has an impact on human health. The linkage between the environmental change and disease dynamics has been highlighted in recent times and hence, emphasis on environmental sustainability to reduce future epidemics. Present book focusses on the relationship between climatic change and epidemiological factors with an approach to reduce the global hotspots. The climatic changes relevant to periods of activity and variations in geographical distribution is addressed including interconnection of sustainability, population growth and environmental change. Features: Covers environmental management and waste to resource for future. Includes guidelines for analysis, assessment, and interventions for waste management. Discusses environmental impediments in the way of healthcare inclusions. Impresses upon the importance of clinical epidemiology to detect, treat, control, and prevent the spread of non-communicable diseases globally. Provides insights for the future health hazards that can be administered at the insignificant stage. This book aims at Graduate Students, Researchers, Professionals and Health Care Professionals in environmental engineering, waste management, climate change, and healthcare.

This textbook presents epidemiology in a practical manner, contextualized with discussions of theory and ethics, so that students and professionals from all academic backgrounds may develop a deep appreciation for how to conduct and interpret epidemiological research. Readers will develop skills to: -Search for and appraise literature critically, -Develop important research questions, -Design and implement studies to address those questions, -Perform and interpret fundamental statistical estimations and tests, -Consider the ethical implications of all stages of research, -Report findings in publications, and -Advocate for change in the public health setting. Epidemiology is and will remain a discipline in motion, and this textbook aims at reflecting this dynamism and keeping pace with its momentum. This textbook is not only a classroom tool with high utility but also an essential reference and guide for those engaging in research involving human subjects.

This book presents futuristic trends in computational intelligence including algorithms as applicable to different application domains in health informatics covering bio-medical, bioinformatics, and biological sciences. Latest evolutionary approaches to solve optimization problems under biomedical engineering field are discussed. It provides conceptual framework with a focus on application of computational intelligence techniques in the domain of biomedical engineering and health informatics including real-time issues.

Towards a Digital Health Ecology : NHS Digital Adoption through the COVID-19 Looking Glass is about technology adoption in the UK's National Health Service (NHS) as told from the inflection point of a disaster. In 2020 the world lived through a disaster of epic proportions, devastating humanity around the globe. It took a microscopic virus to wreak havoc on our healthcare system and force the adoption of technology in a way that had never been seen before. This book tells the story of digital technology take-up in the NHS through the lens of that disaster. This book documents use of technology in the NHS through the lens of the first pandemic shock. Our healthcare system, paid for by general taxation and free at the point of demand, was conceived and developed in a firmly analogue world. Created in 1948, the NHS predates the invention of the World Wide Web by some forty years. This is not a book simply about technology, it is a study of the painful process of reengineering a mammoth and byzantine system that was built for a different era. The digital health sector is a microcosm of the wider healthcare system, through which grand themes of social inequality, public trust, private versus commercial interests, values and beliefs are played out. The sector is a clash of competing discourses: the civic and doing good for society; the market and wealth creation; the industrial creating more efficient and effective systems; the project expressed as innovation and experimentation; lastly the notion of vitality and leading a happier, healthy life. Each of these discourses exists in a state of flux and tension with the other. This book is offered as a critique of the role of digital technologies within healthcare. It is an examination of competing interests, approaches, and ideologies. It is a story of system complexity told through analysis and personal stories.

The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using accessible language, providing technical details, real-world examples, and SAS and R code to implement analyses. The updated ICH guideline raises new analytic and cross-functional challenges for statisticians. Gaps between different communities have come to surface, such as between causal inference and clinical trialists, as well as among clinicians, statisticians, and regulators when it comes to communicating decision-making objectives, assumptions, and interpretations of evidence. This book lays out a path toward bridging some of these gaps. It offers ? A common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges ? A thorough treatment of intercurrent events (ICEs), i.e., postrandomization events that confound interpretation of outcomes and five strategies for ICEs in ICH E9 (R1) ? Details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs: ? A perspective on the role of the intention-to-treat principle ? Examples and case studies from various areas ? Example code in SAS and R ? A connection with causal inference ? Implications and methods for analysis of longitudinal trials with missing data Together, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial and academic perspective.

Provides an excellent grounding in the basics of both statistics and epidemiology. Full step-by-step guidance on performing statistical calculations. Numerous examples and exercises with detailed answers to help readers navigate these complex subjects with ease and confidence. Enables students and practitioners to make sense of the many research studies that underpin evidence-based practice. Fully revised and updated for this fifth edition, now with additional exercises and question and answers online for self-testing.

This book provides a comprehensive overview of the concept of "Total Exposure Health" and presents details on subject areas which make up the framework. It provides in-depth coverage of the science and technology supporting exposure and risk assessment. This includes advances in toxicology and the "-omics" as well as new techniques for exposure assessment. The book concludes with a discussion on bioethics implications, including ethical considerations related to genetic testing. Discusses advances in exposure monitoring Presents a systems biology approach to human exposures Examines how overall well-being translates to worker productivity Considers the link between work-related risk factors and health conditions Covers the study of genomics in precision medicine and exposure science Explores bioethics in genomic studies Aimed at the exposure professionals (industrial hygienists, toxicologists, public health, environmental engineers), geneticists, molecular biologists, engineers and managers in the health and safety industry as well as professionals in the public administration field.

The U.S. healthcare system is in "complete chaos-disarray." Medical costs have increased significantly over the past 6 years with 70% increase for deductibles and 24% or more for health insurance premiums. All the while, workers earnings have either not increased or if they did, the pay raises were for less than the increase in the cost of medical care. The situation is unsustainable and the public wants the system fixed. This book offers ways of fixing the problems in healthcare. HEALTHCARE's OUT SICK - PREDICTING A CURE - Solutions that WORK !!!! first defines the "healthcare in crisis" problem. Through real patient experiences, the book describes the difficulties of getting through the maze of complexity among the plethora of "silo providers" which make up the industry. The heart of the book provides readers with a comprehensive solution that can work, a disruption that is necessary to provide Americans the medical care they need without the US public and healthcare providers and payors going into bankruptcy, insolvency or closure. This book delves into digitized medicine, payor and provider reimbursement models, and value-based healthcare delivery. It also includes a philosophy or mode of thinking and operation for the solutions that are needed for diagnosis-effective, cost-effective, and time-efficient healthcare delivery, of which digitized medicine, value-based care, and payor reimbursement modes are just some of the factors. The authors propose that the real solution involves having the patient at the center of the issues and changing from an archaic gold standard way of thinking to a "Predictive Analytic thinking" where one gets at the real truth by doing "real science" that in the end becomes effective not only for the population but for the individual person. This all leads to real person-centered and person-directed medicine and healthcare delivery.

This volume examines the ongoing, worldwide epidemiological transition in which acute infectious diseases are being superseded by chronic diseases as the predominant causes of morbidity and mortality; age at death has shifted from childhood to older adult ages; and life expectancy, population, and the proportion of older people are increasing. This transition constitutes a fundamental change in the human condition, and an understanding of the historical process behind it is thus of major importance. This study is the first to document the transition in a single country, drawing on records of cause-specific mortality since the eighteenth century in England, with comparative data from other Western countries. Alexander Mercer discusses possible causes of specific disease trends, reassessing the relative importance of "health interventions" and "standard of living" as determinants of increased life expectancy, and presents a new theory of how chronic diseases have developed. As specific microorganisms have been established as causal agents in chronic diseases that account for a significant proportion of "premature" deaths, the study suggests that a new conceptualization of the epidemiological transition is required, one that takes into account interrelationships between infectious diseases, between infections and chronic diseases, and between disorders underlying different chronic diseases. Alexander Mercer is an independent researcher and the author of Disease, Mortality and Population in Transition: Epidemiological-Demographic Change in England Since the Eighteenth Century as Part of a Global Phenomenon.

Continual improvements in data collection and processing have had a huge impact on brain research, producing data sets that are often large and complicated. By emphasizing a few fundamental principles, and a handful of ubiquitous techniques, Analysis of Neural Data provides a unified treatment of analytical methods that have become essential for contemporary researchers. Throughout the book ideas are illustrated with more than 100 examples drawn from the literature, ranging from electrophysiology, to neuroimaging, to behavior. By demonstrating the commonality among various statistical approaches the authors provide the crucial tools for gaining knowledge from diverse types of data. Aimed at experimentalists with only high-school level mathematics, as well as computationally-oriented neuroscientists who have limited familiarity with statistics, Analysis of Neural Data serves as both a self-contained introduction and a reference work.

Global simultaneous development is becoming more necessary as the cost of developing medical products continues to grow. The strategy of using multiregional clinical trials (MRCTs) has become the preferred method for developing new medicines. Implementing the same protocol to include subjects from many geographical regions around the world, MRCTs can speed up the patient enrolment, thus resulting in quicker drug development and obtaining faster approval of the drug globally. After the publication of the editors' first volume on this topic, there have been new developments on MRCTs. The International Council for Harmonisation (ICH) issued ICH E17, a guideline document on MRCTs, in November 2017, laying out principles on MRCTs. Beyond E17, new methodologies have been developed as well. Simultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17 collects chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. In addition, in contrast to the first book, new perspectives are brought to MRCT from regulatory agencies. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products. It will also be especially helpful for statisticians in regulatory agencies, and medical research institutes. This book is comprehensive across the MRCT topic spectrum, including Issues regarding ICH E17 Implementation MRCT Design and Analysis Methodologies Perspectives from authorities in regulatory agencies, as well as statisticians practicing in the medical product industry Many examples of real-life applications based on actual MRCTs.

Healthcare is important to everyone, yet large variations in its quality have been well documented both between and within many countries. With demand and expenditure rising, it's more crucial than ever to know how well the healthcare system and all its components - from staff member to regional network - are performing. This requires data, which inevitably differ in form and quality. It also requires statistical methods, the output of which needs to be presented so that it can be understood by whoever needs it to make decisions. Statistical Methods for Healthcare Performance Monitoring covers measuring quality, types of data, risk adjustment, defining good and bad performance, statistical monitoring, presenting the results to different audiences and evaluating the monitoring system itself. Using examples from around the world, it brings all the issues and perspectives together in a largely non-technical way for clinicians, managers and methodologists. Statistical Methods for Healthcare Performance Monitoring is aimed at statisticians and researchers who need to know how to measure and compare performance, health service regulators, health service managers with responsibilities for monitoring performance, and quality improvement scientists, including those involved in clinical audits.

The integrated nested Laplace approximation (INLA) is a recent computational method that can fit Bayesian models in a fraction of the time required by typical Markov chain Monte Carlo (MCMC) methods. INLA focuses on marginal inference on the model parameters of latent Gaussian Markov random fields models and exploits conditional independence properties in the model for computational speed. Bayesian Inference with INLA provides a description of INLA and its associated R package for model fitting. This book describes the underlying methodology as well as how to fit a wide range of models with R. Topics covered include generalized linear mixed-effects models, multilevel models, spatial and spatio-temporal models, smoothing methods, survival analysis, imputation of missing values, and mixture models. Advanced features of the INLA package and how to extend the number of priors and latent models available in the package are discussed. All examples in the book are fully reproducible and datasets and R code are available from the book website. This book will be helpful to researchers from different areas with some background in Bayesian inference that want to apply the INLA method in their work. The examples cover topics on biostatistics, econometrics, education, environmental science, epidemiology, public health, and the social sciences.

The cost for bringing new medicine from discovery to market has nearly doubled in the last decade and has now reached $2.6 billion. There is an urgent need to make drug development less time-consuming and less costly. Innovative trial designs/ analyses such as the Bayesian approach are essential to meet this need. This book will be the first to provide comprehensive coverage of Bayesian applications across the span of drug development, from discovery, to clinical trial, to manufacturing with practical examples. This book will have a wide appeal to statisticians, scientists, and physicians working in drug development who are motivated to accelerate and streamline the drug development process, as well as students who aspire to work in this field. The advantages of this book are: Provides motivating, worked, practical case examples with easy to grasp models, technical details, and computational codes to run the analyses Balances practical examples with best practices on trial simulation and reporting, as well as regulatory perspectives Chapters written by authors who are individual contributors in their respective topics Dr. Mani Lakshminarayanan is a researcher and statistical consultant with more than 30 years of experience in the pharmaceutical industry. He has published over 50 articles, technical reports, and book chapters besides serving as a referee for several journals. He has a PhD in Statistics from Southern Methodist University, Dallas, Texas and is a Fellow of the American Statistical Association. Dr. Fanni Natanegara has over 15 years of pharmaceutical experience and is currently Principal Research Scientist and Group Leader for the Early Phase Neuroscience Statistics team at Eli Lilly and Company. She played a key role in the Advanced Analytics team to provide Bayesian education and statistical consultation at Eli Lilly. Dr. Natanegara is the chair of the cross industry-regulatory-academic DIA BSWG to ensure that Bayesian methods are appropriately utilized for design and analysis throughout the drug-development process.

- The first practical introduction to second-order and growth mixture models using Mplus 8.4 -Introduces simple and complex models through incremental steps with increasing complexity -Each model is presented with figures with associated syntax that highlight what the statistics mean, Mplus applications, and an interpretation of results, to maximize understanding. - Second-order and growth mixture modeling is increasingly being used in various disciplines to analyze changes in individual attributes such as personal behaviors and relationships over time