pragmatic randomized clinical trials using primary data collection and electronic health records

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Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records
Author : Cynthia J. Girman,Mary Elizabeth Ritchey
Publisher : Academic Press
Release Date : 2021-04-01
ISBN 10 : 0128176644
Pages : 500 pages

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. The book contains chapters encompassing common designs, along with the 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 such 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 biostatitians, but also for several members of biomedical field who are interested in applying pragmatic randomized clinical trials in their research. Brings typical designs and challenges of pragmatic randomized clinical trials (pRCTs) Encompasses analytic aspects for sample size determination of such trials Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records

Clinical Trials
Author : Timothy M. Pawlik,Julie A. Sosa
Publisher : Springer Nature
Release Date : 2020-03-10
ISBN 10 : 3030354881
Pages : 258 pages

This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.

Prevention Practice in Primary Care
Author : Sherri Sheinfeld Gorin
Publisher : Oxford University Press
Release Date : 2013-11
ISBN 10 : 0195373014
Pages : 336 pages

Prevention Practice in Primary Care systematically explores state-of-the-art practical approaches to effective prevention in primary care. Guided by theory and evidence, the book reviews approaches to risk factor identification and modification for the major causes of mortality in adulthood, including cancer, stroke, and cardiovascular disease.

Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
Publisher : John Wiley & Sons
Release Date : 2019-10-23
ISBN 10 : 1119413427
Pages : 1208 pages

This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.

Capturing Social and Behavioral Domains in Electronic Health Records
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Recommended Social and Behavioral Domains and Measures for Electronic Health Records
Publisher : National Academies Press
Release Date : 2014-06-23
ISBN 10 : 0309301130
Pages : 136 pages

Substantial empirical evidence of the contribution of social and behavioral factors to functional status and the onset and progression of disease has accumulated over the past few decades. Electronic health records (EHRs) provide crucial information to providers treating individual patients, to health systems, including public health officials, about the health of populations, and to researchers about the determinants of health and the effectiveness of treatment. Inclusion of social and behavioral health domains in EHRs is vital to all three uses. The Health Information Technology for Economic and Clinical Health Act and the Patient Protection and Affordable Care Act place new importance on the widespread adoption and meaningful use of EHRs. "Meaningful use" in a health information technology context refers to the use of EHRs and related technology within a health care organization to achieve specified objectives. Achieving meaningful use also helps determine whether an organization can receive payments from the Medicare EHR Incentive Program or the Medicaid EHR Incentive Program. Capturing Social and Behavioral Domains in Electronic Health Records is the first phase of a two-phase study to identify domains and measures that capture the social determinants of health to inform the development of recommendations for meaningful use of EHRs. This report identifies specific domains to be considered by the Office of the National Coordinator, specifies criteria that should be used in deciding which domains should be included, identifies core social and behavioral domains to be included in all EHRs, and identifies any domains that should be included for specific populations or settings defined by age, socioeconomic status, race/ethnicity, disease, or other characteristics.

The Learning Healthcare System
Author : Institute of Medicine,Roundtable on Evidence-Based Medicine
Publisher : National Academies Press
Release Date : 2007-06-01
ISBN 10 : 9780309133937
Pages : 374 pages

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.

Registries for Evaluating Patient Outcomes
Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
Release Date : 2014-04-01
ISBN 10 : 1587634333
Pages : 356 pages

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.

Best Care at Lower Cost
Author : Institute of Medicine,Committee on the Learning Health Care System in America
Publisher : National Academies Press
Release Date : 2013-06-10
ISBN 10 : 0309260736
Pages : 436 pages

America's health care system has become too complex and costly to continue business as usual. Best Care at Lower Cost explains that inefficiencies, an overwhelming amount of data, and other economic and quality barriers hinder progress in improving health and threaten the nation's economic stability and global competitiveness. According to this report, the knowledge and tools exist to put the health system on the right course to achieve continuous improvement and better quality care at a lower cost. The costs of the system's current inefficiency underscore the urgent need for a systemwide transformation. About 30 percent of health spending in 2009--roughly $750 billion--was wasted on unnecessary services, excessive administrative costs, fraud, and other problems. Moreover, inefficiencies cause needless suffering. By one estimate, roughly 75,000 deaths might have been averted in 2005 if every state had delivered care at the quality level of the best performing state. This report states that the way health care providers currently train, practice, and learn new information cannot keep pace with the flood of research discoveries and technological advances. About 75 million Americans have more than one chronic condition, requiring coordination among multiple specialists and therapies, which can increase the potential for miscommunication, misdiagnosis, potentially conflicting interventions, and dangerous drug interactions. Best Care at Lower Cost emphasizes that a better use of data is a critical element of a continuously improving health system, such as mobile technologies and electronic health records that offer significant potential to capture and share health data better. In order for this to occur, the National Coordinator for Health Information Technology, IT developers, and standard-setting organizations should ensure that these systems are robust and interoperable. Clinicians and care organizations should fully adopt these technologies, and patients should be encouraged to use tools, such as personal health information portals, to actively engage in their care. This book is a call to action that will guide health care providers; administrators; caregivers; policy makers; health professionals; federal, state, and local government agencies; private and public health organizations; and educational institutions.

Clinical Research Computing
Author : Prakash Nadkarni
Publisher : Academic Press
Release Date : 2016-04-29
ISBN 10 : 012803145X
Pages : 240 pages

Clinical Research Computing: A Practitioner’s Handbook deals with the nuts-and-bolts of providing informatics and computing support for clinical research. The subjects that the practitioner must be aware of are not only technological and scientific, but also organizational and managerial. Therefore, the author offers case studies based on real life experiences in order to prepare the readers for the challenges they may face during their experiences either supporting clinical research or supporting electronic record systems. Clinical research computing is the application of computational methods to the broad field of clinical research. With the advent of modern digital computing, and the powerful data collection, storage, and analysis that is possible with it, it becomes more relevant to understand the technical details in order to fully seize its opportunities. Offers case studies, based on real-life examples where possible, to engage the readers with more complex examples Provides studies backed by technical details, e.g., schema diagrams, code snippets or algorithms illustrating particular techniques, to give the readers confidence to employ the techniques described in their own settings Offers didactic content organization and an increasing complexity through the chapters

Examining the Impact of Real-World Evidence on Medical Product Development
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release Date : 2019-04-05
ISBN 10 : 030948832X
Pages : 230 pages

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.

Secondary Analysis of Electronic Health Records
Author : MIT Critical Data
Publisher : Springer
Release Date : 2016-09-09
ISBN 10 : 3319437429
Pages : 427 pages

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.

Hospital and Health Administration Index
Author : N.A
Publisher : N.A
Release Date : 1999
ISBN 10 :
Pages : 329 pages

Clinical Research Informatics
Author : Rachel Richesson,James Andrews
Publisher : Springer Science & Business Media
Release Date : 2012-02-15
ISBN 10 : 1848824475
Pages : 422 pages

The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.

Oxford Textbook of Primary Medical Care
Author : Roger Jones (Prof.)
Publisher : N.A
Release Date : 2004
ISBN 10 : 9780198567837
Pages : 1299 pages

Clinical Gerontology
Author : T.L. Brink
Publisher : Routledge
Release Date : 2014-04-04
ISBN 10 : 1317840259
Pages : 532 pages

Here is a major text in psychogeriatrics for all professionals in the field of aging and mental health. Leading authorities provide valuable insights into assessment and intervention techniques for use with the mentally impaired elderly. Topics include a depression scale for use in later life, family therapy, therapy in later life, and various issues concerning mental health care for the aged.

Design and Analysis of Group-randomized Trials
Author : David M. Murray
Publisher : Oxford University Press, USA
Release Date : 1998
ISBN 10 : 0195120361
Pages : 467 pages

This text provides the most comprehensive treatment of the design and analytic issues involved in group-randomized trials. GRTs are comparative studies conducted to evaluate the effect of a health promotion intervention in which the units of assignment are identifiable groups (e.g., schools, worksites) and the units of observation are members of those groups (e.g., students, workers). The book reviews the underlying issues, the most widely used research designs, and analytic strategies. There is an emphasis on mixed-model regression, with two chapters illustrating the analytic methods in SAS PROC MIXED and GLIMMIX. There is also a detailed chapter on power analysis and sample size calculation.

Design and Analysis of Quality of Life Studies in Clinical Trials
Author : Diane L. Fairclough
Publisher : CRC Press
Release Date : 2010-01-07
ISBN 10 : 1420061186
Pages : 424 pages

Design Principles and Analysis Techniques for HRQoL Clinical TrialsSAS, R, and SPSS examples realistically show how to implement methods Focusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition addresses design and analysis aspects in enough detail so that readers can apply statistical meth

Virtual Clinical Trials
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release Date : 2019-11-16
ISBN 10 : 0309494885
Pages : 126 pages

Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

Envisioning a Transformed Clinical Trials Enterprise in the United States
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release Date : 2012-09-13
ISBN 10 : 0309253187
Pages : 248 pages

There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.

Closing the Quality Gap
Author : Kaveh G. Shojania
Publisher : N.A
Release Date : 2004
ISBN 10 : 9781587632594
Pages : 7 pages