Download or read book Adverse Events written by Jill A. Fisher and published by NYU Press. This book was released on 2020-05-12 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explores the social inequality of clinical drug testing and its effects on scientific results Imagine that you volunteer for the clinical trial of an experimental drug. The only direct benefit of participating is that you will receive up to $5,175. You must spend twenty nights literally locked in a research facility. You will be told what to eat, when to eat, and when to sleep. You will share a bedroom with several strangers. Who are you, and why would you choose to take part in this kind of study? This book explores the hidden world of pharmaceutical testing on healthy volunteers. Drawing on two years of fieldwork in clinics across the country and 268 interviews with participants and staff, it illustrates how decisions to take part in such studies are often influenced by poverty and lack of employment opportunities. It shows that healthy participants are typically recruited from African American and Latino/a communities, and that they are often serial participants, who obtain a significant portion of their income from these trials. This book reveals not only how social inequality fundamentally shapes these drug trials, but it also depicts the important validity concerns inherent in this mode of testing new pharmaceuticals. These highly controlled studies bear little resemblance to real-world conditions, and everyone involved is incentivized to game the system, ultimately making new drugs appear safer than they really are. Adverse Events provides an unprecedented view of the intersection of racial inequalities with pharmaceutical testing, signaling the dangers of this research enterprise to both social justice and public health.
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Download or read book Beyond Adverse Events written by Layo Emmanuel, MD and published by Independently Published. This book was released on 2024-04-25 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Beyond Adverse Events: A Deep Dive into Drug Safety and Signal Detection" offers a comprehensive exploration of the intricate world of pharmacovigilance, providing readers with a detailed understanding of the principles, methodologies, and practices essential for ensuring the safety and efficacy of pharmaceutical products. From laying the foundational knowledge to exploring cutting-edge advancements, this book aims to equip healthcare professionals, researchers, regulators, and students with the tools and insights necessary to navigate the complex terrain of drug safety with confidence and clarity. Structured into eight parts, each delving into specific aspects of drug safety and signal detection, "Beyond Adverse Events" serves as a comprehensive guide for anyone involved in the field of pharmacovigilance. Offering a thorough examination of drug safety and signal detection from foundational principles to cutting-edge advancements, the book empowers readers through practical examples, case studies, and insightful discussions. It aims to enable them to contribute effectively to the ongoing efforts to safeguard patient health and well-being in an ever-evolving healthcare landscape.
Download or read book Adverse Effects of Vaccines written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-26 with total page 894 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children. Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma. Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Download or read book Patient Safety and Quality written by Ronda Hughes and published by Department of Health and Human Services. This book was released on 2008 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043)." - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/
Download or read book Assessment of Long Term Health Effects of Antimalarial Drugs When Used for Prophylaxis written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-24 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events.
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Placebo and Nocebo Effects in Psychiatry and Beyond written by Paul Enck and published by Frontiers Media SA. This book was released on 2020-10-08 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt: This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact.
Download or read book Beyond Anthrax written by Larry I. Lutwick and published by Springer Science & Business Media. This book was released on 2008-12-15 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biological warfare has, unfortunately, in the post 9/11 world become a significant topic of discussion in both the medical and lay presses. In the wake of the biological "letter bombs" containing anthrax spores, the possibility of biologic and/or toxic attacks on civilians in any part of the world became no longer a possibility. It is now part of common discussion and consciousness. This book presents the history of the topics and clinically relevant discussions on those high risk (Category A) diseases beyond anthrax as well as a number of infections and toxins at the Category B level. Importantly, in addition, the text includes sections on Public Health Infrastructure, Public Health Law, Surveillance, Mental Health Management and Media Role all of which relate to epidemics of any sort, not just intentional biological events. Beyond Anthrax: The Weaponization of Infectious Diseases is a product that should serve as a reference point for clinicians, epidemiologists and public health personnel to understand in practical detail many of the aspects of weapons of biowarfare as well as the appropriate responses to them.
Download or read book Beyond Survival written by Truman G. Packard and published by World Bank Publications. This book was released on 2006-06-20 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'Beyond Survival' breaks new ground in the ongoing debate about health finance and financial protection from the costs of health care. The evidence and discussion support the need to consider financial protection, in addition to health status, as a policy objective when setting priorities for health systems. This book reviews the Latin American experience with health reform in the last 20 years and the fundamentals of health system financing, using new evidence to show the magnitude and mechanisms that determine the impoverishing effects of health events (diseases, accidents, and those of the life cycle). It provides options for policy makers on how to protect, and help household to protect themselves,against this impoverishment. The authors use empirical evidence from six case studies commissioned for this report, on Argentina, Chile, Colombia, Ecuador, Honduras, and Mexico. This book provides policy makers with a solid conceptual basis for decisions on the contents of mandatory health insurance benefit packages, choices of financing mechanisms, and the roles of public policy in this field. 'Beyond Survival' provides an in-depth analysis of, and organizational alternatives for, risk pooling and health insurance for financial protection. It analyzes the urgent need to extend risk pooling to the informal sector, the challenges for current social insurance arrangements, and options for policy makers to effectively extend risk pooling to the informal sector.
Download or read book Patient Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2003-12-20 with total page 551 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans should be able to count on receiving health care that is safe. To achieve this, a new health care delivery system is needed â€" a system that both prevents errors from occurring, and learns from them when they do occur. The development of such a system requires a commitment by all stakeholders to a culture of safety and to the development of improved information systems for the delivery of health care. This national health information infrastructure is needed to provide immediate access to complete patient information and decision-support tools for clinicians and their patients. In addition, this infrastructure must capture patient safety information as a by-product of care and use this information to design even safer delivery systems. Health data standards are both a critical and time-sensitive building block of the national health information infrastructure. Building on the Institute of Medicine reports To Err Is Human and Crossing the Quality Chasm, Patient Safety puts forward a road map for the development and adoption of key health care data standards to support both information exchange and the reporting and analysis of patient safety data.
Download or read book Infant Formula written by Institute of Medicine and published by National Academies Press. This book was released on 2004-06-10 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infant formulas are unique because they are the only source of nutrition for many infants during the first 4 to 6 months of life. They are critical to infant health since they must safely support growth and development during a period when the consequences on inadequate nutrition are most severe. Existing guidelines and regulations for evaluating the safety of conventional food ingredients (e.g., vitamins and minerals) added to infant formulas have worked well in the past; however they are not sufficient to address the diversity of potential new ingredients proposed by manufacturers to develop formulas that mimic the perceived and potential benefits of human milk. This book, prepared at the request of the Food and Drug Administration (FDA) and Health Canada, addresses the regulatory and research issues that are critical in assessing the safety of the addition of new ingredients to infants.
Download or read book Beyond Medication written by David Garfield and published by Routledge. This book was released on 2013-12-16 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Beyond Medication focuses on the creation and evolution of the therapeutic relationship as the agent of change in the recovery from psychosis. Organized from the clinician’s point of view, this practical guidebook moves directly into the heart of the therapeutic process with a sequence of chapters that outline the progressive steps of engagement necessary to recovery. Both the editors and contributors challenge the established medical model by placing the therapeutic relationship at the centre of the treatment process, thus supplanting medication as the single most important element in recovery. Divided into three parts, topics of focus include: Strengthening the patient The mechanism of therapeutic change Sustaining the therapeutic approach. This book will be essential reading for all mental health professionals working with psychosis including psychoanalysts, psychiatrists, psychologists and social workers.
Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Managing Adaptation to Climate Risk written by Geoff O'Brien and published by Routledge. This book was released on 2013-07-24 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: Climate change is the single largest threat to the attainment of the Millennium Development Goals (MDGs) and sustainable development. Addressing climate risk is a challenge for all. This book calls for greater collaboration between climate communities and disaster development communities. In discussing this, the book will evaluate the approaches used by each community to reduce the adverse effects of climate change. One area that offers some promise for bringing together these communities is through the concept of resilience. This term is increasingly used in each community to describe a process that embeds capacity to respond to and cope with disruptive events. This emphasizes an approach that is more focused on pre-event planning and using strategies to build resilience to hazards in an adaptation framework. The book will conclude by evaluating the scope for a holistic approach where these communities can effectively contribute to building communities that are resilient to climate driven risks.
