Developing A Protocol For Observational Comparative Effectiveness Research A User S Guide

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Developing A Protocol For Observational Comparative Effectiveness Research A User S Guide
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Author : Agency for Health Care Research and Quality (U.S.)
language : en
Publisher: Government Printing Office
Release Date : 2013-02-21
Developing A Protocol For Observational Comparative Effectiveness Research A User S Guide written by Agency for Health Care Research and Quality (U.S.) and has been published by Government Printing Office this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-21 with Medical categories.
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)
Finding What Works In Health Care
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-06-20
Finding What Works In Health Care written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-06-20 with Medical categories.
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.
Pharmacoepidemiology
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Author : Brian L. Strom
language : en
Publisher: John Wiley & Sons
Release Date : 2019-12-16
Pharmacoepidemiology written by Brian L. Strom and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-12-16 with Medical categories.
Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.
Registries For Evaluating Patient Outcomes
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Author : Richard E. Gliklich
language : en
Publisher:
Release Date : 2014
Registries For Evaluating Patient Outcomes written by Richard E. Gliklich and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with Diseases categories.
Developing A Protocol For Observational Comparative Effectiveness Research
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Author : Quintiles Outcome (Firm)
language : en
Publisher:
Release Date : 2013
Developing A Protocol For Observational Comparative Effectiveness Research written by Quintiles Outcome (Firm) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Hospital patients categories.
Implementation Research In Health
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Author : David H. Peters
language : en
Publisher: World Health Organization
Release Date : 2013
Implementation Research In Health written by David H. Peters and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Medical categories.
Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.
Real World Evidence In A Patient Centric Digital Era
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Author : Kelly H. Zou
language : en
Publisher: CRC Press
Release Date : 2022-08-03
Real World Evidence In A Patient Centric Digital Era written by Kelly H. Zou and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-08-03 with Mathematics categories.
Real-world evidence is defined as evidence generated from real-world data outside randomized controlled trials. As scientific discoveries and methodologies continue to advance, real-world data and their companion technologies offer powerful new tools for evidence generation. Real-World Evidence in a Patient-Centric Digital Era provides perspectives, examples, and insights on the innovative application of real-world evidence to meet patient needs and improve healthcare, with a focus on the pharmaceutical industry. This book presents an overview of key analytical issues and best practices. Special attention is paid to the development, methodologies, and other salient features of the statistical and data science techniques that are customarily used to generate real-world evidence. It provides a review of key topics and emerging trends in cutting-edge data science and health innovation. Features: Provides an overview of statistical and analytic methodologies in real-world evidence to generate insights on healthcare, with a special focus on the pharmaceutical industry Examines timely topics of high relevance to industry such as bioethical considerations, regulatory standards, and compliance requirements Highlights emerging and current trends, and provides guidelines for best practices Illustrates methods through examples and use-case studies to demonstrate impact Provides guidance on software choices and digital applications for successful analytics Real-World Evidence in a Patient-Centric Digital Era will be a vital reference for medical researchers, health technology innovators, data scientists, epidemiologists, population health analysts, health economists, outcomes researchers, policymakers, and analysts in the healthcare industry.
Practice Based Clinical Inquiry In Nursing For Dnp And Phd Research
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Author : Joan R. Bloch
language : en
Publisher: Springer Publishing Company
Release Date : 2016-02-11
Practice Based Clinical Inquiry In Nursing For Dnp And Phd Research written by Joan R. Bloch and has been published by Springer Publishing Company this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-02-11 with Medical categories.
Meticulously compiled to serve the specific needs of APRNs and nurse executives engaged in doctoral-level research, this text provides evidence-based and practice-based scholarly methods not traditionally taught in PhD or DNP programs. Building on and expanding traditional nursing research methods, the book focuses on both existing and evolving methods of clinical inquiry, some of which incorporate technology and knowledge from other disciplines. These are approaches that can be translated into clinical practice, providing the nursing profession with unprecedented opportunities for collaboration in improving health and health care systems. Methods include quality improvement, implementation science, logic models, program planning and evaluation, patient-engaged and community participatory research, dissemination research, big data, comparative effectiveness research, and systematic reviews. Chapters provide clear guidance on why and how to use a particular method, and are consistently organized to enable a comparison and contrast of different approaches in order to select the one that best fits a particular research need. The text highlights the importance of each approach, and discusses why to use a particular method for doctoral nursing work. Chapters describe how to apply the method along with how to interpret findings and disseminate them. The description of each method concludes with examples from the published literature. Practical tips for impact and success in research and program proposals add further to the text's value. Key Features: Presents research methods specifically for doctoral-level evidence-based and practice-based clinical research Describes interdisciplinary health care methodologies focused on evidence-based improvement in health care Offers practical information on why and how to use each method Provides examples of each method from published literature Written by experienced academic and practice scholars from across the U.S.
Benefit Risk Assessment Methods In Medical Product Development
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Author : Qi Jiang
language : en
Publisher: CRC Press
Release Date : 2017-12-19
Benefit Risk Assessment Methods In Medical Product Development written by Qi Jiang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-19 with Mathematics categories.
Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.
The Science Of Health Disparities Research
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Author : Irene Dankwa-Mullan
language : en
Publisher: John Wiley & Sons
Release Date : 2021-03-16
The Science Of Health Disparities Research written by Irene Dankwa-Mullan and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-03-16 with Science categories.
Integrates the various disciplines of the science of health disparities in one comprehensive volume The Science of Health Disparities Research is an indispensable source of up-to-date information on clinical and translational health disparities science. Building upon the advances in health disparities research over the past decade, this authoritative volume informs policies and practices addressing the diseases, disorders, and gaps in health outcomes that are more prevalent in minority populations and socially disadvantaged communities. Contributions by recognized scholars and leaders in the field—featuring contemporary research, conceptual models, and a broad range of scientific perspectives—provide an interdisciplinary approach to reducing inequalities in population health, encouraging community engagement in the research process, and promoting social justice. In-depth chapters help readers better understand the specifics of minority health and health disparities while demonstrating the importance of advancing theory, refining measurement, improving investigative methods, and diversifying scientific research. In 26 chapters, the book examines topics including the etiology of health disparities research, the determinants of population health, research ethics, and research in African American, Asians, Latino, American Indian, and other vulnerable populations. Providing a unified framework on the principles and applications of the science of health disparities research, this important volume: Defines the field of health disparities science and suggests new directions in scholarship and research Explains basic definitions, principles, and concepts for identifying, understanding and addressing health disparities Provides guidance on both conducting health disparities research and translating the results Examines how social, historical and contemporary injustices may influence the health of racial and ethnic minorities Illustrates the increasing national and global importance of addressing health disparities Discusses population health training, capacity-building, and the transdisciplinary tools needed to advance health equity A significant contribution to the field, The Science of Health Disparities Research is an essential resource for students and basic and clinical researchers in genetics, population genetics, and public health, health care policymakers, and epidemiologists, medical students, and clinicians, particularly those working with minority, vulnerable, or underserved populations.