This book describes some of the key epidemiological principles, scientific approaches and quality assurance frameworks required to design and conduct biobank studies in various settings. Using examples from contemporary biobanks, the book addresses the design features and practical procedures needed in order to launch and manage biobank studies, including consent and regulatory approval, the organisation of field work, management of data and biological samples, follow-up and verification of disease outcomes, development of IT systems for data collection, quality assurance and study management. Over the last two decades, several large biobank studies have been initiated in different populations, intended to greatly enhance the development of precision medicine. Contemporary biobank studies are extremely large and complex, and involve several decades of follow-up. Such studies pose major challenges in terms of ensuring rapid recruitment, obtaining high-quality data, minimising loss to follow-up, reliably classifying disease outcomes, and optimising the use of the biological samples collected. In this regard, the key to success lies not in planning the perfect study, but in planning the most appropriate, reliable, sustainable and future-proof study given the practical constraints of available resources, time and capacity. The authors of this handbook are epidemiologists, clinicians, software engineers, and laboratory and data scientists with extensive experience in conducting large biobank studies. The eight chapters can be read separately or together, and provide readers with essential information on how to design, implement and manage these studies. The state-of-the-art, innovative and scalable approaches and methodologies presented here are intended to stimulate the development of further population-based and hospital-based biobank studies in diverse populations.

To successfully conduct an epidemiological study, academic subject knowledge must be combined with careful consideration of the practical elements involved. From an academic perspective, insights into the basis of epidemiology, the concepts behind how we study diseases, and the challenges and limitations of the results that emerge are prioritised. However, the success of the academic analysis depends on how, when, and where the data used is collected. Epidemiological Studies: A Practical Guide focuses on the practical challenges of epidemiological data collection. Essential topics, such as how to choose the population to study, how to maximise participation and retention, and how to frame questions so that subjects provide the information required, are the core of the material presented. The book explains the skills needed to conduct a study where data is collected and presented accurately, and in appropriate formats. In addition to presenting a step-by-step guide to epidemiological investigations, the chapters in the book are accompanied by examples of how to phrase the letters and forms needed for each stage of conducting a study. Focusing on measurement, study designs, statistics, methodological issues, and key skills, the book provides a valuable background to epidemiological study. With detailed tables and figures, a clear chapter outline, and a straightforward index, the information presented is easily accessible and can quickly be applied to the reader's own work. Extensively revised, this new edition includes updates on case-crossover, Mendelian randomisation, and case-cohort. New chapters have been added to reflect the areas a student is now likely to encounter in an introductory epidemiological course, such as evidence synthesis, use of routine data, association or causation, feasibility, and pilot studies. Epidemiological Studies: A Practical Guide is ideal for students in epidemiology, public health, health research, and health services research. It is also highly relevant to post-graduate research students, and early stage clinical and non-clinical researchers.

This book shares cutting-edge evidence on Hereditary Breast and Ovarian Cancer (HBOC) treatment, delivering facts on breast cancer, gynecologic oncology, and basic research to contribute to clinicians' practices. Each chapter presents the latest clinical techniques, basic experimental results, and the best-chosen research findings. The book is based on the works presented at the Japanese Organization of Hereditary Brest and Ovarian Cancer (JOHBOC) and a special chapter delivers a study based on the extensive data from the Japanese HBOC patients registered in the society's database, presenting novel evidence for further advancement in the field. The practice for HBOC has been rapidly increasing due to the clinical development of poly(ADP-ribose) polymerase inhibitors and the spread of companion diagnostics. In addition, the insurance coverage of a part of HBOC treatment raised social awareness in Japan, and the book illustrates not only clinical efforts but also issues related to the social system and the efforts of the association of related organizations. Hereditary Breast and Ovarian Cancer – Annual meeting of JOHBOC will be of interest to breast surgeons, obstetricians and gynecologists, pancreatic cancer surgeons, and urologists engaged in HBOC treatment through the implementation of companion diagnostics for PARP inhibitors administration. Also, physicians occupied in genetic medicine who perform genetic testing and medical staff practicing HBOC will find this book insightful. It is also for HBOC patients and their families, medical administrators in the social system of HBOC practice. Editors and authors hope to contribute to the equalization and widespread of HBOC practice and serve as a foundation for future advances in the disease's treatment and medical practice.

Health Informatics (HI) focuses on the application of information technology (IT) to the field of medicine to improve individual and population healthcare delivery, education and research. This extensively updated fifth edition reflects the current knowledge in Health Informatics and provides learning objectives, key points, case studies and references. Topics include: HI Overview; Healthcare Data, Information, and Knowledge; Electronic Health Records, Practice Management Systems; Health Information Exchange; Data Standards; Architectures of Information Systems;Health Information Privacy and Security; HI Ethics; Consumer HI; Mobile Technology; Online Medical Resources; Search Engines; Evidence-Based Medicine and Clinical Practice Guidelines; Disease Management and Registries; Quality Improvement Strategies; Patient Safety; Electronic Prescribing; Telemedicine; Picture Archiving and Communication Systems; Bioinformatics; Public HI; E-Research. Available as a printed copy and E-book.

In an age when electronic health records (EHRs) are an increasingly important source of data, this essential textbook provides both practical and theoretical guidance to researchers conducting epidemiological or clinical analysis through EHRs. Split into three parts, the book covers the research journey from start to finish. Part 1 focuses on the challenges inherent when working with EHRs, from access to data management, and raising issues such as completeness and accuracy which impact the validity of any research project. Part 2 examines the core research process itself, with chapters on research design, sampling, and analysis, as well as emerging methodological techniques. Part 3 demonstrates how EHR research can be made meaningful, from presentation to publication, and includes how findings can be applied to real-world issues of public health. Supported by case studies throughout, and applicable across a range of research software programs (including R, SPSS, and SAS), this is the ideal text for students and researchers engaging with EHRs across epidemiological and clinical research.

Neuropathology, Volume 145, the latest release in the Handbook of Clinical Neurology series, includes all the major topics found in a typical neuropathology text, but differentiates itself by providing a thorough overview of the morphological background of neurological disorders for researchers and clinicians who do not specialize in pathology or its clinicopathological aspects. This volume offers strong coverage of brain imaging and advances in molecular pathology and genetics, and is particularly timely given the amount of neuropathological research currently taking place. - Provides a resource for the non-pathologist, aiding primary clinicians and researchers in the interpretation of patient symptoms and research findings - Includes standard neuropathology, but extends to clinicopathology, imaging and molecular pathology/genetics - Presents an interdisciplinary approach that can be applied in everyday clinic and research efforts

Reciprocity in Population Biobanks: Relational Autonomy and the Duty to Inform in the Genomic Era begins by discussing how current judicial interpretation keeps standard of disclosure at the core of genomic research. The book then outlines multiple limitations individualistic autonomy faces in the context of gene and population biobanks, including an analysis of the complexities of benefit considerations in the research setting. Second, the book explores how individualistic autonomy fails to acknowledge the multilateral relationships implicated in genomic research, including those that affect the broader research community, research participants' families, and the general public. In carrying out this analysis, this book pays special attention to alternative approaches and ways researchers, public health officials, and judicial bodies might interact in years to come. In other words, implementing an understanding of relational autonomy that acknowledges and sustains the multilateral relationships found in genomic research without compromising the rights of participants. In short, this book proposes a reconceived duty to inform for researchers and a new standard of disclosure that is more meaningful and impactful for research participants and researchers. - Examines the limitations individualistic autonomy faces in the context of gene and population biobanks - Proposes a reconceived duty to inform for researchers and a new standard of disclosure more meaningful to genomic research participants - Suggests ways researchers, public health officials, and judicial bodies might interact to drive genomic research while still protecting research participants

This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.

This volume is the first comprehensive text on human biobanking, authored by scientists and regulatory officers who have led the field over the past 10 years. It covers biobanking issues and its importance in advancing the field of research in cancer, cardiovascular, metabolic, and other diseases. Biobanks of human specimens have become the cornerstone for research on human health that harnesses the power of “omics” technologies to identify biomarkers for disease susceptibility. Biobanks are an essential component of the development of personalized medicine, which relies on the molecular analysis of biospecimens that are truly representative of individuals and of diseases. Over the past decade, biobanking has been the focus of major investments and developments aimed at developing appropriate infrastructure, methods, networking practice and evidence-based pre-analytical procedures. This volume explores topics including specimen storage, protocol design, specimen collection, pre-analytical processing and preservation, long-term storage, retrieval and separation, and distribution to analytical laboratory platforms. These activities are extremely complex and are essential for biomedical and biotechnological developments and this text provides critical information about biobanking for the development of future forms of medicine.​

Health Informatics (HI) focuses on the application of Information Technology (IT) to the field of medicine to improve individual and population healthcare delivery, education and research. This extensively updated fifth edition reflects the current knowledge in Health Informatics and provides learning objectives, key points, case studies and references.