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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Informed consent - the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention - is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. Regulations that govern the attainment of informed consent for treatment and research are crucial to ensuring that medical care and research are conducted in an ethical manner and with the utmost respect for individual preferences and dignity. These regulations, however, often require - or are perceived to require - that informed consent documents and related materials contain language that is beyond the comprehension level of most patients and study participants. To explore what actions can be taken to help close the gap between what is required in the informed consent process and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine's Roundtable on Health Literacy convened a one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients. Topics covered in this workshop included an overview of the ethical imperative to gain informed consent from patients and research participants, a review of the current state and best practices for informed consent in research and treatment, the connection between poor informed consent processes and minority underrepresentation in research, new approaches to informed consent that reflect principles of health literacy, and the future of informed consent in the treatment and research settings. Informed Consent and Health Literacy is the summary of the presentations and discussion of the workshop.
Covering everything from historical and international perspectives to basic science and current clinical practice, Miller's Anesthesia, 9th Edition, remains the preeminent reference in the field. Dr. Michael Gropper leads a team of global experts who bring you the most up-to-date information available on the technical, scientific, and clinical issues you face each day - whether you're preparing for the boards, studying for recertification, or managing a challenging patient care situation in your practice. Contains fully revised and updated content throughout, including numerous new videos online. Includes four new chapters: Clinical Care in Extreme Environments: High Pressure, Immersion, and Hypo- and Hyperthermia; Immediate and Long-Term Complications; Clinical Research; and Interpreting the Medical Literature. Addresses timely topics such as neurotoxicity, palliation, and sleep/wake disorders. Streamlines several topics into single chapters with fresh perspectives from new authors, making the material more readable and actionable. Features the knowledge and expertise of former lead editor Dr. Ronald Miller, as well as new editor Dr. Kate Leslie of the University of Melbourne and Royal Melbourne Hospital. Provides state-of-the-art coverage of anesthetic drugs, guidelines for anesthetic practice and patient safety, new techniques, step-by-step instructions for patient management, the unique needs of pediatric patients, and much more - all highlighted by more than 1,500 full-color illustrations for enhanced visual clarity. Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices, in addition to accessing regular updates, related websites, and an expanded collection of procedural videos.
Informed consent - as an ethical ideal and legal doctrine - has been the source of much concern to clinicians. Drawing on a diverse set of backgrounds and two decades of research in clinical settings, the authors - a lawyer, a physician, a social scientist, and a philosopher - help clinicians understand and cope with their legal obligations and show how the proper handling of informed consent can improve , rather than impede, patient care. Following a concise review of the ethical and legal foundations of informed consent, they provide detailed, practical suggestions for incorporating informed consent into clinical practice. This completely revised and updated edition discusses how to handle informed consent in all phases of the doctor-patient relationship, use of consent forms, patients' refusals of treatment, and consent to research. It comments on recent laws and national policy, and addresses cutting edge issues, such as fulfilling physician obligations under managed care. This clear and succinct book contains a wealth of information that will not only help clinicians meet the legal requirements of informed consent and understand its ethical underpinnings, but also enhance their ability to deal with their patients more effectively. It will be of value to all those working in areas where issues of informed consent are likely to arise, including medicine, biomedical research, mental health care, nursing, dentistry, biomedical ethics, and law.
The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
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.
Family caregiving affects millions of Americans every day, in all walks of life. At least 17.7 million individuals in the United States are caregivers of an older adult with a health or functional limitation. The nation's family caregivers provide the lion's share of long-term care for our older adult population. They are also central to older adults' access to and receipt of health care and community-based social services. Yet the need to recognize and support caregivers is among the least appreciated challenges facing the aging U.S. population. Families Caring for an Aging America examines the prevalence and nature of family caregiving of older adults and the available evidence on the effectiveness of programs, supports, and other interventions designed to support family caregivers. This report also assesses and recommends policies to address the needs of family caregivers and to minimize the barriers that they encounter in trying to meet the needs of older adults.
"... Aims to assist people in correctly identifying whether an individual has the capacity to make their own decisions."--P. 6.