Statistical Procedures For The Medical Device Industry
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Basic Statistical Techniques for Medical and Other Professionals
Author | : David J. Smith |
Publisher | : CRC Press |
Total Pages | : 91 |
Release | : 2021-10-25 |
Genre | : Business & Economics |
ISBN | : 1000469581 |
We are bombarded with statistical data each and every day, and healthcare professionals are no exception. All sectors of healthcare rely on data provided by insurance companies, consultants, research firms, and government to help them make a host of decisions regarding the delivery of medical services. But while these health professionals rely on data, do they really make the best use of the information? Not if they fail to understand whether the assumptions behind the formulas generating the numbers make sense. Not if they don’t understand that the world of healthcare is flooded with inaccurate, misleading, and even dangerous statistics. The purpose of this book is to provide members of medical and other professions, including scientists and engineers, with a basic understanding of statistics and probability together with an explanation and worked examples of the techniques. It does not seek to confuse the reader with in-depth mathematics but provides basic methods for interpreting data and making inferences. The worked examples are medically based, but the principles apply to the analysis of any numerical data.
Statistical Methods for Healthcare Performance Monitoring
Author | : Alex Bottle |
Publisher | : CRC Press |
Total Pages | : 292 |
Release | : 2016-08-05 |
Genre | : Mathematics |
ISBN | : 1482246104 |
Healthcare is important to everyone, yet large variations in its quality have been well documented both between and within many countries. With demand and expenditure rising, it’s more crucial than ever to know how well the healthcare system and all its components – from staff member to regional network – are performing. This requires data, which inevitably differ in form and quality. It also requires statistical methods, the output of which needs to be presented so that it can be understood by whoever needs it to make decisions. Statistical Methods for Healthcare Performance Monitoring covers measuring quality, types of data, risk adjustment, defining good and bad performance, statistical monitoring, presenting the results to different audiences and evaluating the monitoring system itself. Using examples from around the world, it brings all the issues and perspectives together in a largely non-technical way for clinicians, managers and methodologists. Statistical Methods for Healthcare Performance Monitoring is aimed at statisticians and researchers who need to know how to measure and compare performance, health service regulators, health service managers with responsibilities for monitoring performance, and quality improvement scientists, including those involved in clinical audits.
Registries for Evaluating Patient Outcomes
Author | : Agency for Healthcare Research and Quality/AHRQ |
Publisher | : Government Printing Office |
Total Pages | : 385 |
Release | : 2014-04-01 |
Genre | : Medical |
ISBN | : 1587634333 |
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.
Medical Device Regulations
Author | : Michael Cheng |
Publisher | : World Health Organization |
Total Pages | : 54 |
Release | : 2003-09-16 |
Genre | : Medical |
ISBN | : 9241546182 |
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Rare Diseases and Orphan Products
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 442 |
Release | : 2011-04-03 |
Genre | : Medical |
ISBN | : 0309158060 |
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Clinical Evaluation of Medical Devices
Author | : Karen M. Becker |
Publisher | : Springer Science & Business Media |
Total Pages | : 342 |
Release | : 2007-11-05 |
Genre | : Technology & Engineering |
ISBN | : 1597450049 |
The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.
Modern Methods of Clinical Investigation
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 241 |
Release | : 1990-02-01 |
Genre | : Medical |
ISBN | : 0309042860 |
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.
Statistical Procedures for Agricultural Research
Author | : Kwanchai A. Gomez |
Publisher | : John Wiley & Sons |
Total Pages | : 698 |
Release | : 1984-02-17 |
Genre | : Technology & Engineering |
ISBN | : 9780471870920 |
Here in one easy-to-understand volume are the statistical procedures and techniques the agricultural researcher needs to know in order to design, implement, analyze, and interpret the results of most experiments with crops. Designed specifically for the non-statistician, this valuable guide focuses on the practical problems of the field researcher. Throughout, it emphasizes the use of statistics as a tool of research—one that will help pinpoint research problems and select remedial measures. Whenever possible, mathematical formulations and statistical jargon are avoided. Originally published by the International Rice Research Institute, this widely respected guide has been totally updated and much expanded in this Second Edition. It now features new chapters on the analysis of multi-observation data and experiments conducted over time and space. Also included is a chapter on experiments in farmers' fields, a subject of major concern in developing countries where agricultural research is commonly conducted outside experiment stations. Statistical Procedures for Agricultural Research, Second Edition will prove equally useful to students and professional researchers in all agricultural and biological disciplines. A wealth of examples of actual experiments help readers to choose the statistical method best suited for their needs, and enable even the most complicated procedures to be easily understood and directly applied. An International Rice Research Institute Book
Medical Devices and the Public's Health
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 318 |
Release | : 2011-11-25 |
Genre | : Medical |
ISBN | : 0309212421 |
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.