Download or read book Medical Effectiveness Research Data Methods Conference written by and published by . This book was released on 1991 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Download or read book Medical Effectiveness Research Data Methods written by Mary L. Grady and published by . This book was released on 1992 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Redesigning the Clinical Effectiveness Research Paradigm written by Institute of Medicine and published by National Academies Press. This book was released on 2010-09-20 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scientific and technological advances have accelerated our understanding of the causes of disease development and progression, and resulted in innovative treatments and therapies. Ongoing work to elucidate the effects of individual genetic variation on patient outcomes suggests the rapid pace of discovery in the biomedical sciences will only accelerate. However, these advances belie an important and increasing shortfall between the expansion in therapy and treatment options and knowledge about how these interventions might be applied appropriately to individual patients. The impressive gains made in Americans' health over the past decades provide only a preview of what might be possible when data on treatment effects and patient outcomes are systematically captured and used to evaluate their effectiveness. Needed for progress are advances as dramatic as those experienced in biomedicine in our approach to assessing clinical effectiveness. In the emerging era of tailored treatments and rapidly evolving practice, ensuring the translation of scientific discovery into improved health outcomes requires a new approach to clinical evaluation. A paradigm that supports a continual learning process about what works best for individual patients will not only take advantage of the rigor of trials, but also incorporate other methods that might bring insights relevant to clinical care and endeavor to match the right method to the question at hand. The Institute of Medicine Roundtable on Value & Science-Driven Health Care's vision for a learning healthcare system, in which evidence is applied and generated as a natural course of care, is premised on the development of a research capacity that is structured to provide timely and accurate evidence relevant to the clinical decisions faced by patients and providers. As part of the Roundtable's Learning Healthcare System series of workshops, clinical researchers, academics, and policy makers gathered for the workshop Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches. Participants explored cutting-edge research designs and methods and discussed strategies for development of a research paradigm to better accommodate the diverse array of emerging data resources, study designs, tools, and techniques. Presentations and discussions are summarized in this volume.
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.
Download or read book Applying Comparative Effectiveness Data to Medical Decision Making written by Carl Asche and published by Springer. This book was released on 2015-11-30 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook introduces students to the basic concepts and methods used to measure and compare the expected benefits, risks and cost of preventive and therapeutic medical interventions. It provides an easily accessible overview of comparative effectiveness and its practical applications to daily medical decisions. The book includes learning objectives for each topic, definitions of key terms and topic summaries. Each chapter is written by a highly regarded academic and extensive reference is made throughout to other sources of literature where the interested reader can find further details. The book considers, among other topics, evidence based medicine and the role of comparative effectiveness research in the development of medical guidelines, bias and confounding, quality of life, randomized controlled trials, analyses of retrospective databases, screening and economic evaluation. The book is intended to serve as a “what is it?”, “why do we need it?” and “how does it or could it effect positive change in health care?” rather than just a “how to?” technical overview. As such, it provides an essential resource for both under- and post-graduate students in health sciences.
Download or read book Proceedings of the Public Health Conference on Records and Statistics written by and published by . This book was released on with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Learning What Works written by Institute of Medicine and published by National Academies Press. This book was released on 2011-06-09 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is essential for patients and clinicians to have the resources needed to make informed, collaborative care decisions. Despite this need, only a small fraction of health-related expenditures in the United States have been devoted to comparative effectiveness research (CER). To improve the effectiveness and value of the care delivered, the nation needs to build its capacity for ongoing study and monitoring of the relative effectiveness of clinical interventions and care processes through expanded trials and studies, systematic reviews, innovative research strategies, and clinical registries, as well as improving its ability to apply what is learned from such study through the translation and provision of information and decision support. As part of its Learning Health System series of workshops, the Institute of Medicine's (IOM's) Roundtable on Value & Science-Driven Health Care hosted a workshop to discuss capacity priorities to build the evidence base necessary for care that is more effective and delivers higher value for patients. Learning What Works summarizes the proceedings of the seventh workshop in the Learning Health System series. This workshop focused on the infrastructure needs-including methods, coordination capacities, data resources and linkages, and workforce-for developing an expanded and efficient national capacity for CER. Learning What Works also assesses the current and needed capacity to expand and improve this work, and identifies priority next steps. Learning What Works is a valuable resource for health care professionals, as well as health care policy makers.
Download or read book Cross Design Synthesis written by DIANE Publishing Company and published by DIANE Publishing. This book was released on 1994-03 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: Assesses ways to determine how well medical treatments actually work. Presents a new strategy for medical effectiveness research called "cross design synthesis" which represents an important step in advancing knowledge about the effectiveness of medical treatments, based not only on the results of randomized clinical trials but also on data reflecting wide experience in the field. Charts and tables.
Download or read book Pragmatic Randomized Clinical Trials written by Cynthia J. Girman and published by Academic Press. This book was released on 2021-04-08 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation, and dissemination of pragmatic randomized trials, also sometimes referred to as practical or hybrid randomized trials. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. The book contains chapters encompassing common designs along with advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize pragmatic randomized trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed. This comprehensive resource is valuable not only for pharmacoepidemiologists, biostatisticians and clinical researchers, but also across the biomedical field for those who are interested in applying pragmatic randomized clinical trials in their research. Addresses typical designs and challenges of pragmatic randomized clinical trials (pRCTs) Encompasses analytic aspects of such trials Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records
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)
Download or read book The Science of Real Time Data Capture written by Arthur Stone and published by Oxford University Press. This book was released on 2007-04-19 with total page 411 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Cancer Institute (NCI) has designated the topic of real-time data capture as an important and innovative research area. As such, the NCI sponsored a national meeting of distinguished research scientists to discuss the state of the science in this emerging and burgeoning field. This book reflects the findings of the conference and discusses the state of the science of real-time data capture and its application to health and cancer research. It provides a conceptual framework for minute-by-minute data capture- ecological momentary assessments (EMA)- and discusses health-related topics where these assessements have been applied. In addition, future directions in real-time data capture assessment, interventions, methodology, and technology are discussed. Despite the rapidly growing interest in the methodology of real-time data capture (e.g. journal special issues, widely attended conference presentations, etc.), to date no single book has focused solely on this topic. The volume will serve as an important resource for researchers, students, and government scientists interested in pursuing real-time health research, and will nicely complement our lists in epidemiology, public health, and oncology.
Download or read book Primary Care Research written by and published by . This book was released on 1991 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Secondary Analysis of Electronic Health Records written by MIT Critical Data and published by Springer. This book was released on 2016-09-09 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book trains the next generation of scientists representing different disciplines to leverage the data generated during routine patient care. It formulates a more complete lexicon of evidence-based recommendations and support shared, ethical decision making by doctors with their patients. Diagnostic and therapeutic technologies continue to evolve rapidly, and both individual practitioners and clinical teams face increasingly complex ethical decisions. Unfortunately, the current state of medical knowledge does not provide the guidance to make the majority of clinical decisions on the basis of evidence. The present research infrastructure is inefficient and frequently produces unreliable results that cannot be replicated. Even randomized controlled trials (RCTs), the traditional gold standards of the research reliability hierarchy, are not without limitations. They can be costly, labor intensive, and slow, and can return results that are seldom generalizable to every patient population. Furthermore, many pertinent but unresolved clinical and medical systems issues do not seem to have attracted the interest of the research enterprise, which has come to focus instead on cellular and molecular investigations and single-agent (e.g., a drug or device) effects. For clinicians, the end result is a bit of a “data desert” when it comes to making decisions. The new research infrastructure proposed in this book will help the medical profession to make ethically sound and well informed decisions for their patients.
Download or read book Cross Design Synthesis written by United States. General Accounting Office and published by . This book was released on 1992 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Fundamentals of Evidence Based Health Care and Translational Science written by Francesco Chiappelli and published by Springer Science & Business Media. This book was released on 2014-03-18 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comparative effectiveness research – the conduct and synthesis of systematic research in order to compare the benefits and harms of alternative treatment options – is of critical importance in enabling informed health care decisions to be made. This user-friendly, practical handbook examines in depth how best to perform such comparative effectiveness research. A wide range of topics and methods are discussed, including research synthesis, sampling analysis, assessment of evidence design, systematic evaluation of statistical analysis, and meta-analysis. The discussion extends well beyond the fundamentals by encompassing “complex” systematic reviews, “cumulative” meta-analyses, and logic-based versus utility-based decision making. Health care providers, researchers, instructors, and students will all find this to be an invaluable reference on the compelling current issues and important analytical tools in comparative effectiveness research.
