Study of Self Test Devices


Book Description




Recommendations and guidance on hepatitis C virus self-testing


Book Description

WHO has set a global goal to eliminate HCV as a public health problem by 2030. WHO estimates that 58 million people had chronic hepatitis C virus (HCV) infection globally in 2019, and less than a quarter of them were diagnosed. New and innovative approaches are needed to accelerate progress toward the HCV elimination targets. Self-testing is one such approach. These guidelines provide a new recommendation and guidance on HCV self-testing to complement existing HCV testing services in countries. These guidelines also highlight operational considerations to support strategic implementation and scale up of HCV self-testing.




Registries for Evaluating Patient Outcomes


Book Description

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.




Improving Diagnosis in Health Care


Book Description

Getting the right diagnosis is a key aspect of health care - it provides an explanation of a patient's health problem and informs subsequent health care decisions. The diagnostic process is a complex, collaborative activity that involves clinical reasoning and information gathering to determine a patient's health problem. According to Improving Diagnosis in Health Care, diagnostic errors-inaccurate or delayed diagnoses-persist throughout all settings of care and continue to harm an unacceptable number of patients. It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences. Diagnostic errors may cause harm to patients by preventing or delaying appropriate treatment, providing unnecessary or harmful treatment, or resulting in psychological or financial repercussions. The committee concluded that improving the diagnostic process is not only possible, but also represents a moral, professional, and public health imperative. Improving Diagnosis in Health Care, a continuation of the landmark Institute of Medicine reports To Err Is Human (2000) and Crossing the Quality Chasm (2001), finds that diagnosis-and, in particular, the occurrence of diagnostic errorsâ€"has been largely unappreciated in efforts to improve the quality and safety of health care. Without a dedicated focus on improving diagnosis, diagnostic errors will likely worsen as the delivery of health care and the diagnostic process continue to increase in complexity. Just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers. The recommendations of Improving Diagnosis in Health Care contribute to the growing momentum for change in this crucial area of health care quality and safety.







Psychological Testing in the Service of Disability Determination


Book Description

The United States Social Security Administration (SSA) administers two disability programs: Social Security Disability Insurance (SSDI), for disabled individuals, and their dependent family members, who have worked and contributed to the Social Security trust funds, and Supplemental Security Income (SSSI), which is a means-tested program based on income and financial assets for adults aged 65 years or older and disabled adults and children. Both programs require that claimants have a disability and meet specific medical criteria in order to qualify for benefits. SSA establishes the presence of a medically-determined impairment in individuals with mental disorders other than intellectual disability through the use of standard diagnostic criteria, which include symptoms and signs. These impairments are established largely on reports of signs and symptoms of impairment and functional limitation. Psychological Testing in the Service of Disability Determination considers the use of psychological tests in evaluating disability claims submitted to the SSA. This report critically reviews selected psychological tests, including symptom validity tests, that could contribute to SSA disability determinations. The report discusses the possible uses of such tests and their contribution to disability determinations. Psychological Testing in the Service of Disability Determination discusses testing norms, qualifications for administration of tests, administration of tests, and reporting results. The recommendations of this report will help SSA improve the consistency and accuracy of disability determination in certain cases.




Modern Methods of Clinical Investigation


Book Description

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.







Hematologic Agents—Advances in Research and Application: 2012 Edition


Book Description

Hematologic Agents—Advances in Research and Application: 2012 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Hematologic Agents. The editors have built Hematologic Agents—Advances in Research and Application: 2012 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Hematologic Agents in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Hematologic Agents—Advances in Research and Application: 2012 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.