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Behavioral Clinical Trials for Chronic Diseases

Behavioral Clinical Trials for Chronic Diseases PDF Author: Lynda H. Powell
Publisher: Springer Nature
ISBN: 3030393305
Category : Psychology
Languages : en
Pages : 324

Book Description
This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to “speak the language of medicine” through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.

Behavioral Clinical Trials for Chronic Diseases

Behavioral Clinical Trials for Chronic Diseases PDF Author: Lynda H. Powell
Publisher: Springer Nature
ISBN: 3030393305
Category : Psychology
Languages : en
Pages : 324

Book Description
This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to “speak the language of medicine” through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.

Advances in Patient Safety

Advances in Patient Safety PDF Author: Kerm Henriksen
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 526

Book Description
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Conducting GCP-Compliant Clinical Research

Conducting GCP-Compliant Clinical Research PDF Author: Wendy Bohaychuk
Publisher: John Wiley & Sons
ISBN: 9780471988243
Category : Medical
Languages : en
Pages : 234

Book Description
Conducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including: Standard operating procedures for investigators Standard operating procedures for sponsors and CROs GCP - an indexed reference Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.

Social Neuroscience and Public Health

Social Neuroscience and Public Health PDF Author: Peter A. Hall
Publisher: Springer Science & Business Media
ISBN: 1461468523
Category : Medical
Languages : en
Pages : 319

Book Description
The field of public health is primarily concerned with understanding and improving physical health from a large group perspective (i.e., communities and whole populations). The field of social neuroscience, on the other hand, is primarily concerned with examining brain-behavior relationships that unfold in a social context. Both of these are rapidly developing fields of inquiry, and their boundaries have only recently begun to overlap. This book discusses collaborative research findings at the intersection of social neuroscience and public health that promise to fundamentally change the way scientists, public health practitioners, and the general public view physical health within the larger social context. Eighteen chapters are organized under the following major sections: cognition and health outcomes; neuroscientific aspects of health communication; health behavior and the neurobiology of self-regulation; neurobiological processes in health decision making; ecological and social context; neuroscience methods; and future directions.

Sharing Clinical Trial Data

Sharing Clinical Trial Data PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236

Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Handbook of Health Psychology and Behavioral Medicine

Handbook of Health Psychology and Behavioral Medicine PDF Author: Jerry M. Suls
Publisher: Guilford Press
ISBN: 1606238965
Category : Psychology
Languages : en
Pages : 625

Book Description
What psychological and environmental forces have an impact on health? How does behavior contribute to wellness or illness? This comprehensive volume answers these questions and others with a state-of-the-art overview of theory, research, and practice at the interface of psychology and health. Leading experts from multiple disciplines explore how health and health behaviors are shaped by a wide range of psychological processes and social-environmental factors. The book describes exemplary applications in the prevention and clinical management of today's most pressing health risks and diseases, including coronary heart disease, depression, diabetes, cancer, chronic pain, obesity, sleep disturbances, and smoking. Featuring succinct, accessible chapters on critical concepts and contemporary issues, the Handbook integrates psychological perspectives with cutting-edge work in preventive medicine, epidemiology, public health, genetics, nursing, and the social sciences.

Beyond the HIPAA Privacy Rule

Beyond the HIPAA Privacy Rule PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309124999
Category : Computers
Languages : en
Pages : 334

Book Description
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Principles and Concepts of Behavioral Medicine

Principles and Concepts of Behavioral Medicine PDF Author: Edwin B. Fisher
Publisher: Springer
ISBN: 0387938265
Category : Psychology
Languages : en
Pages : 1132

Book Description
Principles and Concepts of Behavioral Medicine A Global Handbook Edwin B. Fisher, Linda D. Cameron, Alan J. Christensen, Ulrike Ehlert, Brian Oldenburg, Frank J. Snoek and Yan Guo This definitive handbook brings together an international array of experts to present the broad, cells-to-society perspectives of behavioral medicine that complement conventional models of health, health care, and prevention. In addition to applications to assessment, diagnosis, intervention, and management, contributors offer innovative prevention and health promotion strategies informed by current knowledge of the mechanisms and pathways of behavior change. Its range of conceptual and practical topics illustrates the central role of behavior in health at the individual, family, community, and population levels, and its increasing importance to person-centered care. The broad perspectives on risk (e.g., stress, lifestyle), management issues (e.g., adherence, social support), and overarching concerns (e.g., inequities, health policy) makes this reference uniquely global as it addresses the following core areas: · The range of relationships and pathways between behavior and health. · Knowing in behavioral medicine; epistemic foundations. · Key influences on behavior and the relationships among behavior, health, and illness. · Approaches to changing behavior related to health. · Key areas of application in prevention and disease management. · Interventions to improve quality of life. · The contexts of behavioral medicine science and practice. Principles and Concepts of Behavioral Medicine opens out the contemporary world of behavior and health to enhance the work of behavioral medicine specialists, health psychologists, public health professionals and policymakers, as well as physicians, nurses, social workers and those in many other fields of health practice around the world.

Optimization of Behavioral, Biobehavioral, and Biomedical Interventions

Optimization of Behavioral, Biobehavioral, and Biomedical Interventions PDF Author: Linda M. Collins
Publisher: Springer
ISBN: 3319722069
Category : Social Science
Languages : en
Pages : 319

Book Description
This book presents a framework for development, optimization, and evaluation of behavioral, biobehavioral, and biomedical interventions. Behavioral, biobehavioral, and biomedical interventions are programs with the objective of improving and maintaining human health and well-being, broadly defined, in individuals, families, schools, organizations, or communities. These interventions may be aimed at, for example, preventing or treating disease, promoting physical and mental health, preventing violence, or improving academic achievement. This volume introduces the multiphase optimization strategy (MOST), pioneered at The Methodology Center at the Pennsylvania State University, as an alternative to the classical approach of relying solely on the randomized controlled trial (RCT). MOST borrows heavily from perspectives taken and approaches used in engineering, and also integrates concepts from statistics and behavioral science, including the RCT. As described in detail in this book, MOST consists of three phases: preparation, in which the conceptual model underlying the intervention is articulated; optimization, in which experimentation is used to gather the information necessary to identify the optimized intervention; and evaluation, in which the optimized intervention is evaluated in a standard RCT. Through numerous examples, the book demonstrates that MOST can be used to develop interventions that are more effective, efficient, economical, and scalable. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: The Multiphase Optimization Strategy is the first book to present a comprehensive introduction to MOST. It will be an essential resource for behavioral, biobehavioral, and biomedical scientists; statisticians, biostatisticians, and analysts working in epidemiology and public health; and graduate-level courses in development and evaluation of interventions.

Behavioral Intervention Research in Hospice and Palliative Care

Behavioral Intervention Research in Hospice and Palliative Care PDF Author: George Demiris
Publisher: Academic Press
ISBN: 0128144505
Category : Psychology
Languages : en
Pages : 176

Book Description
Behavioral Intervention Research in Hospice and Palliative Care: Building an Evidence Base sets forth research considerations and guidelines to build evidence-based interventions to improve end-of-life care. It is an in-depth introduction to implementation research and showcases how a clinical need is identified to inform an intervention. The book extensively examines the various phases of intervention research, including design, implementation, evaluation, dissemination and translation. The book focuses on methodological, ethical and practical issues. The science behind the quality of hospice and palliative care lags behind that of traditional medical practice, despite the continuous growth of palliative care interdisciplinary teams. Researching, developing and testing strategies is essential to advancing the effectiveness and value of this care. - Informs readers how to conduct intervention research toward identifying best care - Advises readers on design, implementation and evaluation of research - Provides step-by-step templates to develop an intervention study - Includes mock protocols from successful intervention trials - Synthesizes lessons learned by established intervention researchers in hospice and palliative care