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
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.
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
Author: Lynda H. Powell
Publisher:
ISBN: 9783030393298
Category :
Languages : en
Pages : 0
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.
Publisher:
ISBN: 9783030393298
Category :
Languages : en
Pages : 0
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.
Guiding Principles for Developing Dietary Reference Intakes Based on Chronic Disease
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309462568
Category : Medical
Languages : en
Pages : 335
Book Description
Since 1938 and 1941, nutrient intake recommendations have been issued to the public in Canada and the United States, respectively. Currently defined as the Dietary Reference Intakes (DRIs), these values are a set of standards established by consensus committees under the National Academies of Sciences, Engineering, and Medicine and used for planning and assessing diets of apparently healthy individuals and groups. In 2015, a multidisciplinary working group sponsored by the Canadian and U.S. government DRI steering committees convened to identify key scientific challenges encountered in the use of chronic disease endpoints to establish DRI values. Their report, Options for Basing Dietary Reference Intakes (DRIs) on Chronic Disease: Report from a Joint US-/Canadian-Sponsored Working Group, outlined and proposed ways to address conceptual and methodological challenges related to the work of future DRI Committees. This report assesses the options presented in the previous report and determines guiding principles for including chronic disease endpoints for food substances that will be used by future National Academies committees in establishing DRIs.
Publisher: National Academies Press
ISBN: 0309462568
Category : Medical
Languages : en
Pages : 335
Book Description
Since 1938 and 1941, nutrient intake recommendations have been issued to the public in Canada and the United States, respectively. Currently defined as the Dietary Reference Intakes (DRIs), these values are a set of standards established by consensus committees under the National Academies of Sciences, Engineering, and Medicine and used for planning and assessing diets of apparently healthy individuals and groups. In 2015, a multidisciplinary working group sponsored by the Canadian and U.S. government DRI steering committees convened to identify key scientific challenges encountered in the use of chronic disease endpoints to establish DRI values. Their report, Options for Basing Dietary Reference Intakes (DRIs) on Chronic Disease: Report from a Joint US-/Canadian-Sponsored Working Group, outlined and proposed ways to address conceptual and methodological challenges related to the work of future DRI Committees. This report assesses the options presented in the previous report and determines guiding principles for including chronic disease endpoints for food substances that will be used by future National Academies committees in establishing DRIs.
Encyclopedia of Behavioral Medicine
Author: Marc D. Gellman
Publisher:
ISBN: 9781461464396
Category : Clinical health psychology
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9781461464396
Category : Clinical health psychology
Languages : en
Pages :
Book Description
Living Well with Chronic Illness
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309221277
Category : Medical
Languages : en
Pages : 350
Book Description
In the United States, chronic diseases currently account for 70 percent of all deaths, and close to 48 million Americans report a disability related to a chronic condition. Today, about one in four Americans have multiple diseases and the prevalence and burden of chronic disease in the elderly and racial/ethnic minorities are notably disproportionate. Chronic disease has now emerged as a major public health problem and it threatens not only population health, but our social and economic welfare. Living Well with Chronic Disease identifies the population-based public health actions that can help reduce disability and improve functioning and quality of life among individuals who are at risk of developing a chronic disease and those with one or more diseases. The book recommends that all major federally funded programmatic and research initiatives in health include an evaluation on health-related quality of life and functional status. Also, the book recommends increasing support for implementation research on how to disseminate effective longterm lifestyle interventions in community-based settings that improve living well with chronic disease. Living Well with Chronic Disease uses three frameworks and considers diseases such as heart disease and stroke, diabetes, depression, and respiratory problems. The book's recommendations will inform policy makers concerned with health reform in public- and private-sectors and also managers of communitybased and public-health intervention programs, private and public research funders, and patients living with one or more chronic conditions.
Publisher: National Academies Press
ISBN: 0309221277
Category : Medical
Languages : en
Pages : 350
Book Description
In the United States, chronic diseases currently account for 70 percent of all deaths, and close to 48 million Americans report a disability related to a chronic condition. Today, about one in four Americans have multiple diseases and the prevalence and burden of chronic disease in the elderly and racial/ethnic minorities are notably disproportionate. Chronic disease has now emerged as a major public health problem and it threatens not only population health, but our social and economic welfare. Living Well with Chronic Disease identifies the population-based public health actions that can help reduce disability and improve functioning and quality of life among individuals who are at risk of developing a chronic disease and those with one or more diseases. The book recommends that all major federally funded programmatic and research initiatives in health include an evaluation on health-related quality of life and functional status. Also, the book recommends increasing support for implementation research on how to disseminate effective longterm lifestyle interventions in community-based settings that improve living well with chronic disease. Living Well with Chronic Disease uses three frameworks and considers diseases such as heart disease and stroke, diabetes, depression, and respiratory problems. The book's recommendations will inform policy makers concerned with health reform in public- and private-sectors and also managers of communitybased and public-health intervention programs, private and public research funders, and patients living with one or more chronic conditions.
Conducting GCP-Compliant Clinical Research
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.
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.
Sharing Clinical Trial Data
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.
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.
Transforming Clinical Research in the United States
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309163358
Category : Medical
Languages : en
Pages : 151
Book Description
An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
Publisher: National Academies Press
ISBN: 0309163358
Category : Medical
Languages : en
Pages : 151
Book Description
An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
Pain and Behavioral Medicine
Author: Dennis C. Turk
Publisher: Guilford Press
ISBN: 9780898629170
Category : Psychology
Languages : en
Pages : 472
Book Description
This immensely practical volume describes the rationale, development, and utilization of cognitive-behavioral techniques in promoting health, preventing disease, and treating illness, with a particular focus on pain management. An ideal resource for a wide range of practitioners and researchers, the book's coverage of pain management includes theoretical, research, and clinical issues, and includes illustrative case material.
Publisher: Guilford Press
ISBN: 9780898629170
Category : Psychology
Languages : en
Pages : 472
Book Description
This immensely practical volume describes the rationale, development, and utilization of cognitive-behavioral techniques in promoting health, preventing disease, and treating illness, with a particular focus on pain management. An ideal resource for a wide range of practitioners and researchers, the book's coverage of pain management includes theoretical, research, and clinical issues, and includes illustrative case material.
Coping with Chronic Illness
Author: Steven Safren
Publisher: Oxford University Press
ISBN: 0198043031
Category : Psychology
Languages : en
Pages : 131
Book Description
If you suffer from a chronic medical condition like cancer, HIV, diabetes, asthma, or hypertension, you know how hard it can be to perform all the self-care behaviors required of you, especially if you are also dealing with depression. Studies have shown that depressed individuls with chronic illness have a hard time keeping up with the behaviors necessary to manage their condition and improve their health. The program outlined in this workbook can help you take better care of yourself while simultaneously relieving your depression. Designed to be used in conjunction with visits to a qualified mental health professional, this workbook teaches you strategies for maintaining your medical regimen. You will learn how to set up a reminder system for taking medication, plan for getting to medical appointments on time, and how to communicate effectively with your medical providers. You will also learn how to follow the advice of your treatment providers, such as adhering to certain lifestyle and dietary recommendations. These Life-Steps are essential to the program. As you begin to take better care of yourself, you will notice a decrease in your depression. In addition to these self-care skills, you will also learn how to maximize your quality of life, which is another important part of lessening your depressed feelings. Begin to re-engage in pleasurable activities and utilize relaxation techniques and breathing exercises to help you cope with stress and discomfort. Use problem-solving to successfully deal with interpersonal or situational difficulties and change your negative thought through adaptive thinking. By treatment's end you will have all the skills you need to successfully manage your illness and cope with your depression.
Publisher: Oxford University Press
ISBN: 0198043031
Category : Psychology
Languages : en
Pages : 131
Book Description
If you suffer from a chronic medical condition like cancer, HIV, diabetes, asthma, or hypertension, you know how hard it can be to perform all the self-care behaviors required of you, especially if you are also dealing with depression. Studies have shown that depressed individuls with chronic illness have a hard time keeping up with the behaviors necessary to manage their condition and improve their health. The program outlined in this workbook can help you take better care of yourself while simultaneously relieving your depression. Designed to be used in conjunction with visits to a qualified mental health professional, this workbook teaches you strategies for maintaining your medical regimen. You will learn how to set up a reminder system for taking medication, plan for getting to medical appointments on time, and how to communicate effectively with your medical providers. You will also learn how to follow the advice of your treatment providers, such as adhering to certain lifestyle and dietary recommendations. These Life-Steps are essential to the program. As you begin to take better care of yourself, you will notice a decrease in your depression. In addition to these self-care skills, you will also learn how to maximize your quality of life, which is another important part of lessening your depressed feelings. Begin to re-engage in pleasurable activities and utilize relaxation techniques and breathing exercises to help you cope with stress and discomfort. Use problem-solving to successfully deal with interpersonal or situational difficulties and change your negative thought through adaptive thinking. By treatment's end you will have all the skills you need to successfully manage your illness and cope with your depression.