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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.
The revised Tomorrow′s Doctors makes it clear that doctors need to be aware of their responsibilities as scholars and scientists and it is therefore vital that students develop excellent research skills. Whilst there are many ′research skills′ books, medical students frequently struggle with understanding the difference between the practices of research, audit, service evaluation, systematic and narrative reviews and when and how to apply them. This book addresses the kinds of questions novice investigators always ask and helps students utilise study designs, data collection tools and analysis effectively.
This Handbook intends to inform Data Providers and researchers on how to provide privacy-protected access to, handle, and analyze administrative data, and to link them with existing resources, such as a database of data use agreements (DUA) and templates. Available publicly, the Handbook will provide guidance on data access requirements and procedures, data privacy, data security, property rights, regulations for public data use, data architecture, data use and storage, cost structure and recovery, ethics and privacy-protection, making data accessible for research, and dissemination for restricted access use. The knowledge base will serve as a resource for all researchers looking to work with administrative data and for Data Providers looking to make such data available.
Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
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.
The medical research landscape in the United States is supported by a variety of organizations that spend billions of dollars in government and private funds each year to seek answers to complex medical and public health problems. The largest government funder is the National Institutes of Health (NIH), followed by the Department of Defense (DoD). Almost half of DoD's medical research funding is administered by the Congressionally Directed Medical Research Programs (CDMRP). The mission of CDMRP is to foster innovative approaches to medical research in response to the needs of its stakeholdersâ€"the U.S. military, their families, the American public, and Congress. CDMRP funds medical research to be performed by other government and nongovernmental organizations, but it does not conduct research itself. The major focus of CDMRP funded research is the improved prevention, diagnosis, and treatment of diseases, injuries, or conditions that affect service members and their families, and the general public. The hallmarks of CDMRP include reviewing applications for research funding using a two-tiered review process, and involving consumers throughout the process. Evaluation of the Congressionally Directed Medical Research Programs Review Process evaluates the CDMRP two-tiered peer review process, its coordination of research priorities with NIH and the Department of Veterans Affairs, and provides recommendations on how the process for reviewing and selecting studies can be improved.
"While the future of US healthcare is unclear the move toward value-based care is undoubtedly its next major shift. Reimbursement payment programs have already begun this metamorphosis and are increasingly being tied to quality measures. With the urgency of revolutionary change in the background, the healthcare organization must transform its care and business models to evolve into a next-level healthcare enterprise. In Essential Operational Components for High-Performing Healthcare Enterprises, Jon Burroughs and other nationally respected experts highlight the building blocks necessary to transform a healthcare organization into an integrated delivery system. In this operational model, hospitals and other entities in the system work together to achieve common clinical and business goals. Shifting from reactive to proactive, healthcare leaders must move the mindset and strategy of the healthcare system, from caring for the ill to preventing illness. This radical book proposes a framework of innovative strategies for shifting to a fully engaged, aligned, and integrated delivery system: - Effective leadership - The role of clinical staff - Strategic planning - Clinically integrated networks - Health information management - Population health - Actuarial risk and cost management The push for efficiency, quality, and cost reduction demands change in every area of the US healthcare system. Essential Operational Components for High-Performing Healthcare Enterprises defines the fundamental enterprise-wide elements that all healthcare organizations will need to embrace to excel in a value-based world"--
This book offers a comprehensive reference guide to operations research theory and applications in health care systems. It provides readers with all the necessary tools for solving health care problems. The respective chapters, written by prominent researchers, explain a wealth of both basic and advanced concepts of operations research for the management of operating rooms, intensive care units, supply chain, emergency medical service, human resources, lean health care, and procurement. To foster a better understanding, the chapters include relevant examples or case studies. Taken together, they form an excellent reference guide for researchers, lecturers and postgraduate students pursuing research on health care management problems. The book presents a dynamic snapshot on the field that is expected to stimulate new directions and stimulate new ideas and developments.
A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials