Increasing Importance Of Patients Generated Real World Data For Healthcare Policy Decisions About Medicinal Products
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Author |
: Agency for Healthcare Research and Quality/AHRQ |
Publisher |
: Government Printing Office |
Total Pages |
: 385 |
Release |
: 2014-04-01 |
ISBN-10 |
: 9781587634338 |
ISBN-13 |
: 1587634333 |
Rating |
: 4/5 (38 Downloads) |
Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
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 |
: Institute of Medicine |
Publisher |
: National Academies Press |
Total Pages |
: 334 |
Release |
: 2009-03-24 |
ISBN-10 |
: 9780309124997 |
ISBN-13 |
: 0309124999 |
Rating |
: 4/5 (97 Downloads) |
Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine
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 |
: National Academies of Sciences, Engineering, and Medicine |
Publisher |
: National Academies Press |
Total Pages |
: 231 |
Release |
: 2019-04-05 |
ISBN-10 |
: 9780309488327 |
ISBN-13 |
: 030948832X |
Rating |
: 4/5 (27 Downloads) |
Synopsis Examining the Impact of Real-World Evidence on Medical Product Development by : National Academies of Sciences, Engineering, and Medicine
Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.
Author |
: Kenneth K. C. Lee |
Publisher |
: Frontiers Media SA |
Total Pages |
: 112 |
Release |
: 2024-05-09 |
ISBN-10 |
: 9782832548554 |
ISBN-13 |
: 2832548555 |
Rating |
: 4/5 (54 Downloads) |
Synopsis Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions about Medicinal Products, volume II by : Kenneth K. C. Lee
The goal of this proposed Research Topic is to encourage researchers in this field from different jurisdictions to use this as a platform to share their experiences in conducting studies designed in a patient-centric approach using RWD, their encountered areas of concern during the process, and the anticipated impact of their studies.
Author |
: Kenneth K. C. Lee |
Publisher |
: Frontiers Media SA |
Total Pages |
: 156 |
Release |
: 2022-05-03 |
ISBN-10 |
: 9782889760688 |
ISBN-13 |
: 2889760685 |
Rating |
: 4/5 (88 Downloads) |
Synopsis Increasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions About Medicinal Products by : Kenneth K. C. Lee
Author |
: Institute of Medicine |
Publisher |
: National Academies Press |
Total Pages |
: 202 |
Release |
: 2008-09-06 |
ISBN-10 |
: 9780309113694 |
ISBN-13 |
: 0309113695 |
Rating |
: 4/5 (94 Downloads) |
Synopsis Evidence-Based Medicine and the Changing Nature of Health Care by : Institute of Medicine
Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.
Author |
: National Academies of Sciences, Engineering, and Medicine |
Publisher |
: National Academies Press |
Total Pages |
: 103 |
Release |
: 2017-07-05 |
ISBN-10 |
: 9780309455657 |
ISBN-13 |
: 0309455650 |
Rating |
: 4/5 (57 Downloads) |
Synopsis Real-World Evidence Generation and Evaluation of Therapeutics by : National Academies of Sciences, Engineering, and Medicine
The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.
Author |
: Institute of Medicine |
Publisher |
: National Academies Press |
Total Pages |
: 374 |
Release |
: 2007-06-01 |
ISBN-10 |
: 9780309133937 |
ISBN-13 |
: 0309133939 |
Rating |
: 4/5 (37 Downloads) |
Synopsis The Learning Healthcare System by : Institute of Medicine
As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care.
Author |
: Harry Yang |
Publisher |
: CRC Press |
Total Pages |
: 191 |
Release |
: 2021-01-11 |
ISBN-10 |
: 9780429676826 |
ISBN-13 |
: 0429676824 |
Rating |
: 4/5 (26 Downloads) |
Synopsis Real-World Evidence in Drug Development and Evaluation by : Harry Yang
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
Author |
: Agency for Health Care Research and Quality (U.S.) |
Publisher |
: Government Printing Office |
Total Pages |
: 236 |
Release |
: 2013-02-21 |
ISBN-10 |
: 9781587634239 |
ISBN-13 |
: 1587634236 |
Rating |
: 4/5 (39 Downloads) |
Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)
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)