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Book Guidance on Medical Exposures in Medical and Biomedical Research

Download or read book Guidance on Medical Exposures in Medical and Biomedical Research written by European Commission. Directorate-General for Environment, Nuclear Safety, and Civil Protection and published by . This book was released on 1998 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Developing a Protocol for Observational Comparative Effectiveness Research  A User s Guide

Download or read book Developing a Protocol for Observational Comparative Effectiveness Research A User s Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. 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. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

Book Radiation Protection and Safety in Medical Uses of Ionizing Radiation

Download or read book Radiation Protection and Safety in Medical Uses of Ionizing Radiation written by International Atomic Energy Agency and published by . This book was released on 2019-02-04 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Safety Guide provides recommendations and guidance on fulfilling the requirements of IAEA Safety Standards Series No. GSR Part 3 for ensuring radiation protection and safety of radiation sources in medical uses of ionizing radiation with regard to patients, workers, carers and comforters, volunteers in biomedical research, and the public. It covers radiological procedures in diagnostic radiology (including dentistry), image guided interventional procedures, nuclear medicine, and radiotherapy. Recommendations and guidance are provided on applying a systematic approach to ensure that there is a balance between being able to utilize the benefits from medical uses of ionizing radiation and minimizing the risk of radiation effects to people.

Book Radiation in Medicine

    Book Details:
  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release : 1996-03-25
  • ISBN : 0309175674
  • Pages : 321 pages

Download or read book Radiation in Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 1996-03-25 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: Does radiation medicine need more regulation or simply better-coordinated regulation? This book addresses this and other questions of critical importance to public health and safety. The issues involved are high on the nation's agenda: the impact of radiation on public safety, the balance between federal and state authority, and the cost-benefit ratio of regulation. Although incidents of misadministration are rare, a case in Pennsylvania resulting in the death of a patient and the inadvertent exposure of others to a high dose of radiation drew attention to issues concerning the regulation of ionizing radiation in medicine and the need to examine current regulatory practices. Written at the request from the Nuclear Regulatory Commission (NRC), Radiation in Medicine reviews the regulation of ionizing radiation in medicine, focusing on the NRC's Medical Use Program, which governs the use of reactor-generated byproduct materials. The committee recommends immediate action on enforcement and provides longer term proposals for reform of the regulatory system. The volume covers: Sources of radiation and their use in medicine. Levels of risk to patients, workers, and the public. Current roles of the Nuclear Regulatory Commission, other federal agencies, and states. Criticisms from the regulated community. The committee explores alternative regulatory structures for radiation medicine and explains the rationale for the option it recommends in this volume. Based on extensive research, input from the regulated community, and the collaborative efforts of experts from a range of disciplines, Radiation in Medicine will be an important resource for federal and state policymakers and regulators, health professionals involved in radiation treatment, developers and producers of radiation equipment, insurance providers, and concerned laypersons.

Book International Ethical Guidelines for Health Related Research Involving Humans

Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

Book Guidance on Medical Exposures in Medical and Biomedical Research

Download or read book Guidance on Medical Exposures in Medical and Biomedical Research written by Commission of the European Communities. Directorate-General for Environment, Nuclear Safety, and Civil Protection and published by . This book was released on 1998 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Sharing Clinical Trial Data

    Book Details:
  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release : 2015-04-20
  • ISBN : 0309316324
  • Pages : 236 pages

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Book Registries for Evaluating Patient Outcomes

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.

Book Finding What Works in Health Care

Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Book The Belmont Report

    Book Details:
  • Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
  • Publisher :
  • Release : 1978
  • ISBN :
  • Pages : 614 pages

Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Justification of Medical Exposure in Diagnostic Imaging

Download or read book Justification of Medical Exposure in Diagnostic Imaging written by International Atomic Energy Agency and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the proceedings of an international workshop on justification of medical exposure in diagnostic imaging, jointly organized by the International Atomic Energy Agency and the European Commission. The workshop brought together experts from many countries and organizations to discuss how to ensure more effective application of justification in diagnostic imaging. Major areas that need action were identified, such as the coordination of methods and evidence used for basis of clinical imaging recommendations, engagement of all relevant organizations in deployment of these recommendations, and involvement of manufacturers and referring healthcare providers. Furthermore, the important role of education and training was re-emphasized. In the conclusion the workshop participants highlighted that regulatory authorities have a key role in ensuring effective justification, and that an effective partnership with the medical community must be maintained to do this.

Book The Health Effects of Cannabis and Cannabinoids

Download or read book The Health Effects of Cannabis and Cannabinoids written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-03-31 with total page 487 pages. Available in PDF, EPUB and Kindle. Book excerpt: Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk. However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agendaâ€"outlining gaps in current knowledge and opportunities for providing additional insight into these issuesâ€"that summarizes and prioritizes pressing research needs.

Book Artificial Intelligence in Medical Imaging

Download or read book Artificial Intelligence in Medical Imaging written by Erik R. Ranschaert and published by Springer. This book was released on 2019-01-29 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a thorough overview of the ongoing evolution in the application of artificial intelligence (AI) within healthcare and radiology, enabling readers to gain a deeper insight into the technological background of AI and the impacts of new and emerging technologies on medical imaging. After an introduction on game changers in radiology, such as deep learning technology, the technological evolution of AI in computing science and medical image computing is described, with explanation of basic principles and the types and subtypes of AI. Subsequent sections address the use of imaging biomarkers, the development and validation of AI applications, and various aspects and issues relating to the growing role of big data in radiology. Diverse real-life clinical applications of AI are then outlined for different body parts, demonstrating their ability to add value to daily radiology practices. The concluding section focuses on the impact of AI on radiology and the implications for radiologists, for example with respect to training. Written by radiologists and IT professionals, the book will be of high value for radiologists, medical/clinical physicists, IT specialists, and imaging informatics professionals.

Book Advancing Nuclear Medicine Through Innovation

Download or read book Advancing Nuclear Medicine Through Innovation written by National Research Council and published by National Academies Press. This book was released on 2007-09-11 with total page 173 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nearly 20 million nuclear medicine procedures are carried out each year in the United States alone to diagnose and treat cancers, cardiovascular disease, and certain neurological disorders. Many of the advancements in nuclear medicine have been the result of research investments made during the past 50 years where these procedures are now a routine part of clinical care. Although nuclear medicine plays an important role in biomedical research and disease management, its promise is only beginning to be realized. Advancing Nuclear Medicine Through Innovation highlights the exciting emerging opportunities in nuclear medicine, which include assessing the efficacy of new drugs in development, individualizing treatment to the patient, and understanding the biology of human diseases. Health care and pharmaceutical professionals will be most interested in this book's examination of the challenges the field faces and its recommendations for ways to reduce these impediments.

Book Returning Individual Research Results to Participants

Download or read book Returning Individual Research Results to Participants written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-08-23 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

Book Referral Guidelines for Imaging

Download or read book Referral Guidelines for Imaging written by European Commission. Environment Directorate-General and published by . This book was released on 2001 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This booklet sets out referral guidelines that can be used by health professionals qualified to refer patients for imaging. It has evolved from the booklet 'Making the best use of a department of clinical radiology: guidelines for doctors' published by the Royal College of Radiologists in 1998 and can be adopted as a model for Member States. The EU Council Directive 1997/43/EURATOM declared that Member States shall promote the establishment and use of diagnostic reference levels for radiological examinations and guidance thereof. These referral guidelines can be used for that purpose.

Book Radiation Protection and Safety of Radiation Sources

Download or read book Radiation Protection and Safety of Radiation Sources written by International Atomic Energy Agency and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication is the new edition of the International Basic Safety Standards. The edition is co-sponsored by seven other international organizations European Commission (EC/Euratom), FAO, ILO, OECD/NEA, PAHO, UNEP and WHO. It replaces the interim edition that was published in November 2011 and the previous edition of the International Basic Safety Standards which was published in 1996. It has been extensively revised and updated to take account of the latest finding of the United Nations Scientific Committee on the Effects of Atomic Radiation, and the latest recommendations of the International Commission on Radiological Protection. The publication details the requirements for the protection of people and the environment from harmful effects of ionizing radiation and for the safety of radiation sources. All circumstances of radiation exposure are considered.