This manual will help Institutional Review Boards (IRBs) conduct ethics review that balances the major moral considerations in research with human subjects. Current challenges in the IRB environment are addressed with arguments and insights from dozens of scholars. Useful to the IRB member at any level of experience, Balanced Ethics Review provides the necessary tools needed to create a systemic blueprint for promoting the research and dissemination of scientists and scholars within the standard norms of regulation.

Statistical science as organized in formal academic departments is relatively new. With a few exceptions, most Statistics and Biostatistics departments have been created within the past 60 years. This book consists of a set of memoirs, one for each department in the U.S. created by the mid-1960s. The memoirs describe key aspects of the department's history -- its founding, its growth, key people in its development, success stories (such as major research accomplishments) and the occasional failure story, PhD graduates who have had a significant impact, its impact on statistical education, and a summary of where the department stands today and its vision for the future. Read here all about how departments such as at Berkeley, Chicago, Harvard, and Stanford started and how they got to where they are today. The book should also be of interests to scholars in the field of disciplinary history.

Handbook of Spatial Epidemiology explains how to model epidemiological problems and improve inference about disease etiology from a geographical perspective. Top epidemiologists, geographers, and statisticians share interdisciplinary viewpoints on analyzing spatial data and space-time variations in disease incidences. These analyses can provide important information that leads to better decision making in public health. The first part of the book addresses general issues related to epidemiology, GIS, environmental studies, clustering, and ecological analysis. The second part presents basic statistical methods used in spatial epidemiology, including fundamental likelihood principles, Bayesian methods, and testing and nonparametric approaches. With a focus on special methods, the third part describes geostatistical models, splines, quantile regression, focused clustering, mixtures, multivariate methods, and much more. The final part examines special problems and application areas, such as residential history analysis, segregation, health services research, health surveys, infectious disease, veterinary topics, and health surveillance and clustering. Spatial epidemiology, also known as disease mapping, studies the geographical or spatial distribution of health outcomes. This handbook offers a wide-ranging overview of state-of-the-art approaches to determine the relationships between health and various risk factors, empowering researchers and policy makers to tackle public health problems.

Type 1 diabetes is a serious and common disease, afflicting one per 200 of the population worldwide. It is widely believed to cause harmful physical maldevelopment--congenital malformations--and other consequences in the unborn children of women with the disease. This book considers the history of the disease in pregnant women and this belief that it causes anomalies since the time of the discovery of insulin in 1921, and presents a profound and critical appraisal of the subject of its supposed prenatal harmfulness.

Here is a new book on methods and issues in clinical research. Its objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research. The book ends with a brief description of the drug development process and the phases of clinical development.

Molecular epidemiology has recently broaden its focuses due to the development of molecular tools but also by incorporating advances of other fields such as mathematical epidemiology, molecular ecology, population genetics and evolution. Facing new risks of emerging and re-emerging infectious diseases that are threats for humans and their livestock, the objectives of molecular epidemiology include: - the development of molecular tools, genotyping and gene expression - the incorporation of concepts and results of population genetics of infectious diseases - the integration of recent advances in theoretical epidemiology and evolutionary ecology of diseases - a better understanding of transmission for the development of risk factors analyses. This book will demonstrate how the latest developments in molecular tools and in epidemiology can be integrated with studies of host-pathogen interactions. Besides a strong theoretical component, there will also be an emphasis on applications in the fields of epidemiology, public health, veterinary medicine, and health ecology. Students and researchers in the fields of epidemiology, animal and human health, evolutionary ecology, parasitology are the main potential readers of the book, as well as a broader audience from veterinary medicine and conservation.

Gene Expression and its Discontents examines a class of probability models describing how epigenetic context affects gene expression and organismal development, using the asymptotic limit theorems of information theory in a highly formal manner. Taking classic results on spontaneous symmetry breaking abducted from statistical physics in groupoid, rather than group, circumstances, the work suggests that epigenetic information sources act as analogs to a tunable catalyst, directing development into different characteristic pathways according to the structure of external signals. The results have significant implications for epigenetic epidemiology, in particular for understanding how environmental stressors, in a large sense, can induce a broad spectrum of developmental disorders in humans. The authors then apply the perspective to a number of chronic diseases broadly associated with obesity, using data at different scales of observation.

Polycystic ovary syndrome (PCOS) is a classic female infertility condition affecting an estimated 6-10% of all women, many of whom are unaware of the problem. A disease that affects women from adolescence to menopause, PCOS is the single most common endrocrinologic abnormality affecting women. This book is an edited collection of writings that comprehensively covers the disease, from diagnosis and epidemiology of PCOS to clinical evaluation.

This volume contains an advanced level discussion on the appropriateness of hormone replacement therapy (HRT) in modern postmenopausal women on the basis of evidence provided by recent epidemiological studies. It addresses all aspects of benefits and risks associated with HRT. It focuses, however, on cancer risk and on risk of breast cancer in particular. The book advocates further epidemiological studies which incorporate pathobiological assessments.

The best introduction to the terrible international impact of the Black Death. Unique, sensational and shocking, this revelatory book provides the best overview of the Europe-wide history of the Black Death. The author's painstakingly comprehensive research throws fresh light on the nature of the disease, its origin, its spread, on an almost day-to-day basis, across Europe, Asia Minor, the Middle East and North Africa, its mortality rate and its impact on history. These latter two aspects are of central importance here, for it is demonstrated that the plague's death rates have consistently been under-estimated and that they were in fact much higher, making the disease's long-term effects on history even more profound. First paperback edition published 2006. OLE J. BENEDICTOW is Professor of History at the University of Oslo.

Mathematical epidemiology of infectious diseases usually involves describing the flow of individuals between mutually exclusive infection states. One of the key parameters describing the transition from the susceptible to the infected class is the hazard of infection, often referred to as the force of infection. The force of infection reflects the degree of contact with potential for transmission between infected and susceptible individuals. The mathematical relation between the force of infection and effective contact patterns is generally assumed to be subjected to the mass action principle, which yields the necessary information to estimate the basic reproduction number, another key parameter in infectious disease epidemiology. It is within this context that the Center for Statistics (CenStat, I-Biostat, Hasselt University) and the Centre for the Evaluation of Vaccination and the Centre for Health Economic Research and Modelling Infectious Diseases (CEV, CHERMID, Vaccine and Infectious Disease Institute, University of Antwerp) have collaborated over the past 15 years. This book demonstrates the past and current research activities of these institutes and can be considered to be a milestone in this collaboration. This book is focused on the application of modern statistical methods and models to estimate infectious disease parameters. We want to provide the readers with software guidance, such as R packages, and with data, as far as they can be made publicly available.

Japan's asbestos disasters, encompassing both occupational disease and environmental pollution, have been caused principally by the asbestos textile, asbestos cement water pipe, and construction industries. This book is unique in its interdisciplinary approach to those disasters as it incorporates medical science, economics, political science, law, architecture, environmental engineering, sociology, and journalism. Written by authorities in their fields, the chapters reflect the integration of these disciplines in topics that include a historical review of asbestos issues in Japan, asbestos-related diseases, international aspects of the asbestos industry, public policy, divisions of responsibility, relief activities in emergencies, and countermeasures enacted by local governments. The lessons of asbestos problems and policies in Japan are particularly important for developing countries to prevent the proliferation of asbestos disasters. This volume serves as a textbook on asbestos issues for all countries, especially where there is widespread use of asbestos.

Striking a balance between theory, application, and programming, Biostatistics in Public Health Using STATA is a user-friendly guide to applied statistical analysis in public health using STATA version 14. The book supplies public health practitioners and students with the opportunity to gain expertise in the application of statistics in epidemiologic studies. The book shares the authors' insights gathered through decades of collective experience teaching in the academic programs of biostatistics and epidemiology. Maintaining a focus on the application of statistics in public health, it facilitates a clear understanding of the basic commands of STATA for reading and saving databases. The book includes coverage of data description, graph construction, significance tests, linear regression models, analysis of variance, categorical data analysis, logistic regression model, poisson regression model, survival analysis, analysis of correlated data, and advanced programming in STATA. Each chapter is based on one or more research problems linked to public health. Additionally, every chapter includes exercise sets for practicing concepts and exercise solutions for self or group study. Several examples are presented that illustrate the applications of the statistical method in the health sciences using epidemiologic study designs. Presenting high-level statistics in an accessible manner across research fields in public health, this book is suitable for use as a textbook for biostatistics and epidemiology courses or for consulting the statistical applications in public health. For readers new to STATA, the first three chapters should be read sequentially, as they form the basis of an introductory course to this software.

The two parts of this volume feature seventeen and six extended conference abstracts corresponding to selected talks given by participants at "Joint CRM-Imperial College Workshop in Complex Systems" and "Emergence, Spread and Control of Infectious Diseases" respectively, both held at the Centre de Recerca Matematica in Barcelona in spring 2013. Most of them are short articles giving preliminary presentations of new results not yet published in regular research journals. The articles are the result from a direct collaboration among active researchers in the area after working in a dynamic and productive atmosphere.Almost everything that is interesting and important for society is complex; here, examples scattered across science are presented in order to illustrate the cross-disciplinary richness of state-of-the-art complex systems research: fracture avalanches and rain showers that mimic earthquakes; highly organized graphs that account for processes in neural networks, metabolic networks, food webs, or language; models for DNA dynamics; or statistical methods to test complexity in the form of structure along many different scales. The mathematics is put to work for the modeling of the real system, and the models are kept at a minimum level to allow the understanding of the essentials of the real system. The book is intended for established researchers, as well as for PhD and postdoc students who wish to learn more about the latest advances in these active areas of research."

Epidemiology: A Research Manual for South Africa offers an applied introduction to epidemiological research methods, for students of various health science disciplines who are required to conduct or reference epidemiological research. Directed at readers who are new to epidemiological theory and practice, the text explains fundamental concepts and methods in a manner that is clear and accessible. The text offers a step-by-step guide to the development of a research protocol and the application of epidemiological methods, and addresses specific content areas and methodologies that are important in contemporary epidemiological research. Examples focus on the South African setting, highlighting regional conditions, diseases and health services.

This book provides anintroduction to multistate event history analysis. It is an extension of survival analysis, in which a single terminal event (endpoint) is considered and the time-to-event is studied. Multistate models focus on life histories or trajectories, conceptualized as sequences of states and sequences of transitions between states. Life histories are modeled as realizations of continuous-time Markov processes. The model parameters, transition rates, are estimated from data on event counts and populations at risk, using the statistical theory of counting processes.

The Comprehensive R Network Archive (CRAN) includes several packages for multistate modeling. This book is about "Biograph." The package is designed to (a) enhance exploratory analysis of life histories and (b) make multistate modeling accessible. The package incorporates utilities that connect to several packages for multistate modeling, including "survival," "eha," "Epi," "mvna," " etm," "mstate," "msm," and "TraMineR" for sequence analysis. The book is a hands-on presentation of "Biograph" and the packages listed. It is written from the perspective of the user. To help the user master the techniques and the software, a single data set is used to illustrate the methods and software. It is the subsample of the German Life History Survey, which was also used by Blossfeld and Rohwer in their popular textbook on event history modeling. Another data set, the Netherlands Family and Fertility Survey, is used to illustrate how "Biograph" can assist in answering questions on life paths of cohorts and individuals.

The book is suitable as a textbook for graduate courses on event history analysis and introductory courses on competing risks and multistate models. It may also be used as a self-study book. The R code used in the book is available online.

Frans Willekens is affiliated with the Max Planck Institute for Demographic Research (MPIDR) in Rostock, Germany. He is Emeritus Professor of Demography at the University of Groningen, a Honorary Fellow of the Netherlands Interdisciplinary Demographic Institute (NIDI) in the Hague, and a Research Associate of the International Institute for Applied Systems Analysis (IIASA), Laxenburg, Austria. He is a member of Royal Netherlands Academy of Arts and Sciences (KNAW). He has contributed to the modeling and simulation of life histories, mainly in the context of population forecasting."

This book is an introduction to health care as a complex adaptive system, a system that feeds back on itself. The first section introduces systems and complexity theory from a science, historical, epistemological, and technical perspective, describing the principles and mathematics. Subsequent sections build on the health applications of systems science theory, from human physiology to medical decision making, population health and health services research. The aim of the book is to introduce and expand on important population health issues from a systems and complexity perspective, highlight current research developments and their implications for health care delivery, consider their ethical implications, and to suggest directions for and potential pitfalls in the future.

In 1986, the emergence of a novel brain disease in British cattle presented a unique challenge to scientists. How that challenge was addressed has been the subject of a public inquiry and numerous academic studies conducted to date. However, none of these investigations has sought to examine the reasoning of scientists during this critical period in the public health of the UK. Using concepts and techniques in informal logic, argumentation and fallacy theory, this study reconstructs and evaluates the reasoning of scientists in the ten-year period between 1986 and 1996. Specifically, a form of presumptive reasoning is described in which extensive use is made of arguments traditionally identified as informal fallacies. In the context of the adverse epistemic conditions that confronted scientists during the BSE epidemic, these arguments were anything but fallacious, serving instead to confer a number of epistemic gains upon scientific inquiry. This book argues for a closer integration of philosophy with public health science, an integration that is exemplified by the case of scientific reasoning during the BSE affair. It will therefore be of interest to advanced students, academics, researchers and professionals in the areas of public health science and epidemiology, as well as philosophical disciplines such as informal logic, argumentation and fallacy theory and epistemology.

Over the past 40 years the rate of illicit drug use worldwide has risen dramatically, and with it the number of deaths reported among drug-using populations. What are the clinical, ethical and psychopathological implications of these deaths? In this book, Shane Darke and his team provide the first full, synthetic review of the epidemiology, causes, prevalence, demography, and associated risk factors of illicit-drug-related mortality. In addition, they examine and evaluate interventions to reduce these deaths. The major causes of death among illicit drug users are overdose, disease, suicide and trauma. Each is independently examined. This is an important book for all clinicians and policy makers involved in issues relating to illicit drug use.

Having last year published "Up from Clinical Epidemiology & EBM" and also "Epidemiological Research: Terms and Concepts," Miettinen now - this time with collaboration from his junior colleague I. Karp - brings out this further introduction into epidemiological research; and he is now working on an introduction into clinical research, for publication next year. It evidently is Miettinen's felt time to crystallize the basic understandings he has come to as the culmination of a half-century of concentrated effort to advance the theory of epidemiological and 'meta-epidemiological clinical' research. In accord with its title, this book focuses on research to develop the knowledge-base for preventive medicine, which mainly is knowledge about the causal origin -etilogy, etiogenesis - of illness. It first illustrates how wanting this knowledge still is, despite much research; and it then aims to guide the reader to more productive etiogenetic research. This book places much emphasis on the need to assure relevance by principles-guided objects design for the studies, which now remains conspicuously absent from epidemiologists' concerns. And as for methods design, this book exposes the fallacies in the still-common 'cohort' and 'case-control' studies, defines the essentials of all etiogenetic studies, and then addresses the true options for design in this framework of shared essentials. A good deal of attention is also given to the still commonly-held, very major, twin fallacies that screening for an illness is a preventive intervention, to be studied by randomized trials, and that research on it can imply rational guidelines or recommendations regarding decisions about the screening. While Miettinen already is regarded as 'the father of modern epidemiology,' he now appears to have become the father also of post-modern epidemiology, where 'epidemiology' still means epidemiological research.

The human foetus is separated from the maternal blood by the syncytiotrophoblast induced by endogeneous human retrovirus-encoded proteins. This barrier is a highly developed one, which suppors apical-basolateral transport of maternal idiotype and anti-idiotype IgG, IgG-virus complexes. The selective maternal-fetal transport of epitope- and paratope-bearing entities can influence the developping fetal immune system during pregnancy. The bidirectional maternal-fetal transfer of cells are of even more importance during pregnancy. Maternal cells with latent viruses transport viruses without impairment of fetal development. Cells with premaligant and malignant genetic transformation are also transported to the fetus. Fetal and neonatal tumours are initiated by such cells in spite of the antitumour potential of fetal organism. On the contary, the fetal cells repair maternal tissue injouries and survive in the organisms of the recipients for decades. These possess new consequences for the neonatal immunity and organ transplatation surgery.

Routine applications of advanced statistical methods on real data have become possible in the last ten years because desktop computers have become much more powerful and cheaper. However, proper understanding of the challenging statistical theory behind those methods remains essential for correct application and interpretation, and rarely seen in the medical literature. Modern Methods for Epidemiology provides a concise introduction to recent development in statistical methodologies for epidemiological and biomedical researchers. Many of these methods have become indispensible tools for researchers working in epidemiology and medicine but are rarely discussed in details by standard textbooks of biostatistics or epidemiology. Contributors of this book are experienced researchers and experts in their respective fields. This textbook provides a solid starting point for those who are new to epidemiology, and for those looking for guidance in more modern statistical approaches to observational epidemiology. Epidemiological and biomedical researchers who wish to overcome the mathematical barrier of applying those methods to their research will find this book an accessible and helpful reference for self-learning and research. This book is also a good source for teaching postgraduate students in medical statistics or epidemiology.

This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators' language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

The importance of health systems has been reinforced by the commitment of Low- and Middle-Income Countries (L&MICs) to pursue the targets of Universal Health Coverage, Health Security, and to achieve Health-related Sustainable Development Goals. The COVID-19 pandemic has further exposed the fragility of health systems in countries of all income groups. Authored by international experts across five continents, this book demonstrates how health systems can be strengthened in L&MICs by unravelling their complexities and by offering a comprehensive overview of fundamental concepts, performance assessment approaches and improvement strategies to address health system challenges in L&MICs. Centred on evidence and advocacy this unique resource on health systems in L&MICs will benefit a wide range of audiences including, readers engaged in public health practice, educational programs and research initiatives; faculties of public health and population sciences; policymakers, managers and health professionals working for governments, civil society organizations and development agencies in health.

The second edition of this popular textbook provides an introduction to the principles and methods of epidemiology. Since publication of the first edition in 1993, Basic epidemiology has become a standard reference for education, training and research in the field of public health and has been translated into more than 25 languages. It is used widely, for training public health and environment professionals, undergraduate medical students, and students in other health professions. The second edition provides updated examples of how and why the basics of epidemiology are essential to anyone who is required to understand and apply the principles of disease causation and prevention. The book has a particular emphasis on modifiable environmental factors and encourages the application of epidemiology to the prevention of disease and the promotion of health, including environmental and occupational health. It prepares members of the health-related professions to respond to the need for health services to address all aspects of the health of populations, and to ensure that health resources are used to the best possible effect. It shows how good clinical practice is informed by clinical epidemiology; and its lively, concise style is designed to stimulate a continuing interest in the subject. This edition includes comprehensive chapters on the nature and uses of epidemiology; the epidemiological approach to defining and measuring the occurrence of health-related states in populations; the strengths and limitations of epidemiological study designs, causation, the contribution of epidemiology to the prevention of disease, the promotion of health and the development of health policy, and the role of epidemiology in evaluating the effectiveness and efficiency of health care. It enables students to describe the common causes of death, disease and disability in her or his community; outline appropriate study designs to answer specific questions concerning disease causation, natural history, prognosis, prevention, and the evaluation of therapy and other interventions to control disease, and critically evaluate the literature.