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Author: Agency for Healthcare Research and Quality/AHRQ Publisher: Government Printing Office ISBN: 1587634333 Category : Medical Languages : en Pages : 385
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.
Author: Agency for Healthcare Research and Quality/AHRQ Publisher: Government Printing Office ISBN: 1587634333 Category : Medical Languages : en Pages : 385
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.
Author: Frederick W. Faltin Publisher: John Wiley & Sons ISBN: 1119942047 Category : Medical Languages : en Pages : 533
Book Description
Statistical Methods in Healthcare In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed. With a focus on finding solutions to these challenges, this book: Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development. Offers a broad coverage of standards and established methods through leading edge techniques. Uses an integrated case study based approach, with focus on applications. Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance. Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes. Addresses the use of modern statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision. Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 236
Book Description
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.
Author: Jennifer Peat Publisher: John Wiley & Sons ISBN: 0470755202 Category : Medical Languages : en Pages : 336
Book Description
Holistic approach to understanding medical statistics This hands-on guide is much more than a basic medical statistics introduction. It equips you with the statistical tools required for evidence-based clinical research. Each chapter provides a clear step-by-step guide to each statistical test with practical instructions on how to generate and interpret the numbers, and present the results as scientific tables or graphs. Showing you how to: analyse data with the help of data set examples (Click here to download datasets) select the correct statistics and report results for publication or presentation understand and critically appraise results reported in the literature Each statistical test is linked to the research question and the type of study design used. There are also checklists for critically appraising the literature and web links to useful internet sites. Clear and concise explanations, combined with plenty of examples and tabulated explanations are based on the authors’ popular medical statistics courses. Critical appraisal guidelines at the end of each chapter help the reader evaluate the statistical data in their particular contexts.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309124999 Category : Computers Languages : en Pages : 334
Book Description
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.
Author: MIT Critical Data Publisher: Springer ISBN: 3319437429 Category : Medical Languages : en Pages : 435
Book Description
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.
Author: Lance A. Waller Publisher: John Wiley & Sons ISBN: 0471662674 Category : Mathematics Languages : en Pages : 522
Book Description
While mapped data provide a common ground for discussions between the public, the media, regulatory agencies, and public health researchers, the analysis of spatially referenced data has experienced a phenomenal growth over the last two decades, thanks in part to the development of geographical information systems (GISs). This is the first thorough overview to integrate spatial statistics with data management and the display capabilities of GIS. It describes methods for assessing the likelihood of observed patterns and quantifying the link between exposures and outcomes in spatially correlated data. This introductory text is designed to serve as both an introduction for the novice and a reference for practitioners in the field Requires only minimal background in public health and only some knowledge of statistics through multiple regression Touches upon some advanced topics, such as random effects, hierarchical models and spatial point processes, but does not require prior exposure Includes lavish use of figures/illustrations throughout the volume as well as analyses of several data sets (in the form of "data breaks") Exercises based on data analyses reinforce concepts
Author: Robert H. Riffenburgh Publisher: Academic Press ISBN: Category : Business & Economics Languages : en Pages : 680
Book Description
Medicine deals with treatments that work often but not always, so treatment success must be based on probability. Statistical methods lift medical research from the anecdotal to measured levels of probability. This book presents the common statistical methods used in 90% of medical research, along with the underlying basics, in two parts: a textbook section for use by students in health care training programs, e.g., medical schools or residency training, and a reference section for use by practicing clinicians in reading medical literature and performing their own research. The book does not require a significant level of mathematical knowledge and couches the methods in multiple examples drawn from clinical medicine, giving it applicable context. Easy-to-follow format incorporates medical examples, step-by-step methods, and check yourself exercises Two-part design features course material and a professional reference section Chapter summaries provide a review of formulas, method algorithms, and check lists Companion site links to statistical databases that can be downloaded and used to perform the exercises from the book and practice statistical methods New in this Edition: New chapters on: multifactor tests on means of continuous data, equivalence testing, and advanced methods New topics include: trial randomization, treatment ethics in medical research, imputation of missing data, and making evidence-based medical decisions Updated database coverage and additional exercises Expanded coverage of numbers needed to treat and to benefit, and regression analysis including stepwise regression and Cox regression Thorough discussion on required sample size
Author: Agency for Healthcare Research and Quality/AHRQ
Author: Agency for Healthcare Research and Quality/AHRQ
Author: Austin Bradford Hill
Author: Dan Mayer
Author: Frederick W. Faltin
Author: Institute of Medicine
Author: Jennifer Peat
Author: Institute of Medicine
Author: MIT Critical Data
Author: Lance A. Waller
Author: Robert H. Riffenburgh