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Pragmatic Randomized Clinical Trials

Pragmatic Randomized Clinical Trials
  • Author : Cynthia J. Girman,Mary E. Ritchey
  • Publisher :Unknown
  • Release Date :2021-04-23
  • Total pages :498
  • ISBN : 9780128176641
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Summary : 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, also sometimes referred to as practical or hybrid randomized trials. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. The book contains chapters encompassing common designs along with 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 pragmatic randomized 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 pharmacoepidemiologists, biostatisticians and clinical researchers, but also across the biomedical field for those who are interested in applying pragmatic randomized clinical trials in their research. • Addresses typical designs and challenges of pragmatic randomized clinical trials (pRCTs) • Encompasses analytic aspects of such trials • Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records

Clinical Trials

Clinical Trials
  • Author : Timothy M. Pawlik,Julie A. Sosa
  • Publisher :Unknown
  • Release Date :2020-03-10
  • Total pages :258
  • ISBN : 9783030354886
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Summary : 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

Prevention Practice in Primary Care
  • Author : Sherri Sheinfeld Gorin
  • Publisher :Unknown
  • Release Date :2013-11
  • Total pages :336
  • ISBN : 9780195373011
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Summary : 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.

Pharmacoepidemiology

Pharmacoepidemiology
  • Author : Brian L. Strom,Stephen E. Kimmel,Sean Hennessy
  • Publisher :Unknown
  • Release Date :2019-10-23
  • Total pages :1208
  • ISBN : 9781119413424
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Summary : 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.

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
  • Author : Agency for Healthcare Research and Quality/AHRQ
  • Publisher :Unknown
  • Release Date :2014-04-01
  • Total pages :356
  • ISBN : 9781587634338
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Summary : 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.

The Learning Healthcare System

The Learning Healthcare System
  • Author : Institute of Medicine,Roundtable on Evidence-Based Medicine
  • Publisher :Unknown
  • Release Date :2007-06-01
  • Total pages :374
  • ISBN : 0309133939
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Summary : 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.

Clinical Research Computing

Clinical Research Computing
  • Author : Prakash Nadkarni
  • Publisher :Unknown
  • Release Date :2016-04-29
  • Total pages :240
  • ISBN : 9780128031452
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Summary : 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

Secondary Analysis of Electronic Health Records

Secondary Analysis of Electronic Health Records
  • Author : MIT Critical Data
  • Publisher :Unknown
  • Release Date :2016-09-09
  • Total pages :427
  • ISBN : 9783319437422
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Summary : 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.

Oxford Textbook of Primary Medical Care

Oxford Textbook of Primary Medical Care
  • Author : Roger Jones (Prof.)
  • Publisher :Unknown
  • Release Date :2004
  • Total pages :1299
  • ISBN : 0198567839
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Summary :

Best Care at Lower Cost

Best Care at Lower Cost
  • Author : Institute of Medicine,Committee on the Learning Health Care System in America
  • Publisher :Unknown
  • Release Date :2013-06-10
  • Total pages :436
  • ISBN : 9780309260732
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Summary : 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 Informatics

Clinical Research Informatics
  • Author : Rachel Richesson,James Andrews
  • Publisher :Unknown
  • Release Date :2012-02-15
  • Total pages :422
  • ISBN : 9781848824478
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Summary : 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.

Envisioning a Transformed Clinical Trials Enterprise in the United States

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 :Unknown
  • Release Date :2012-09-13
  • Total pages :248
  • ISBN : 9780309253185
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Summary : 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.

Virtual Clinical Trials

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 :Unknown
  • Release Date :2019-11-16
  • Total pages :126
  • ISBN : 9780309494885
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Summary : 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.

Design and Analysis of Group-randomized Trials

Design and Analysis of Group-randomized Trials
  • Author : David M. Murray
  • Publisher :Unknown
  • Release Date :1998
  • Total pages :467
  • ISBN : 9780195120363
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Summary : 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.

Data Quality Assessment

Data Quality Assessment
  • Author : Arkady Maydanchik
  • Publisher :Unknown
  • Release Date :2007-04-01
  • Total pages :336
  • ISBN : 9781634620475
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Summary : Imagine a group of prehistoric hunters armed with stone-tipped spears. Their primitive weapons made hunting large animals, such as mammoths, dangerous work. Over time, however, a new breed of hunters developed. They would stretch the skin of a previously killed mammoth on the wall and throw their spears, while observing which spear, thrown from which angle and distance, penetrated the skin the best. The data gathered helped them make better spears and develop better hunting strategies. Quality data is the key to any advancement, whether it’s from the Stone Age to the Bronze Age. Or from the Information Age to whatever Age comes next. The success of corporations and government institutions largely depends on the efficiency with which they can collect, organize, and utilize data about products, customers, competitors, and employees. Fortunately, improving your data quality doesn’t have to be such a mammoth task. DATA QUALITY ASSESSMENT is a must read for anyone who needs to understand, correct, or prevent data quality issues in their organization. Skipping theory and focusing purely on what is practical and what works, this text contains a proven approach to identifying, warehousing, and analyzing data errors – the first step in any data quality program. Master techniques in: • Data profiling and gathering metadata • Identifying, designing, and implementing data quality rules • Organizing rule and error catalogues • Ensuring accuracy and completeness of the data quality assessment • Constructing the dimensional data quality scorecard • Executing a recurrent data quality assessment This is one of those books that marks a milestone in the evolution of a discipline. Arkady's insights and techniques fuel the transition of data quality management from art to science -- from crafting to engineering. From deep experience, with thoughtful structure, and with engaging style Arkady brings the discipline of data quality to practitioners. David Wells, Director of Education, Data Warehousing Institute

BMJ

BMJ
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1998
  • Total pages :229
  • ISBN : UCLA:L0078438595
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Summary :

Handbook of EHealth Evaluation

Handbook of EHealth Evaluation
  • Author : Francis Yin Yee Lau,Craig Kuziemsky
  • Publisher :Unknown
  • Release Date :2016-11
  • Total pages :487
  • ISBN : 1550586017
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Summary : To order please visit https://onlineacademiccommunity.uvic.ca/press/books/ordering/

Integrating Research and Practice

Integrating Research and Practice
  • Author : Institute of Medicine,Roundtable on Value and Science-Driven Health Care
  • Publisher :Unknown
  • Release Date :2015-03-04
  • Total pages :226
  • ISBN : 9780309312042
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Summary : Health care has been called one of the most complex sectors of the U.S. economy. Driven largely by robust innovation in treatments and interventions, this complexity has created an increased need for evidence about what works best for whom in order to inform decisions that lead to safe, efficient, effective, and affordable care. As health care becomes more digital, clinical datasets are becoming larger and more numerous. By realizing the potential of knowledge generation that is more closely integrated with the practice of care, it should be possible not only to produce more usable evidence to inform decisions, but also to increase the efficiency and decrease the costs of doing clinical research. Patient-Centered Clinical Research Network, or PCORnet, is a nation-wide patient-centered clinical research network intended to form a resource of clinical, administrative, and patient data that can be used to carry out observational and interventional research studies and enhance the use of clinical data to advance the learning health care system. The primary goal of the first phase of PCORnet will be to establish the data infrastructure necessary to do such research. In April and June 2014 the Institute of Medicine's Roundtable on Value and Science-Driven Health Care convened two workshops aimed at accelerating progress toward real-time knowledge generation through the seamless integration of clinical practice and research, one of the fundamental concepts of a continuously learning health system, centered on the development of the PCORnet. The first workshop brought together health care system leaders, both administrative and clinical, and researchers to consider issues and strategic priorities for building a successful and durable clinical research network and facilitate progress toward a continuously learning health care system more broadly, including issues related to science, technology, ethics, business, regulatory oversight, sustainability, and governance. The second workshop focused on implementation approaches. Health system CEOs convened to consider strategic priorities and explore approaches to implementation. These workshops will inform the decisions of field leaders moving forward, including PCORI, the PCORnet steering committee, and PCORnet grantees. Integrating Research and Practice is the summary of the presentations and discussions of the workshops.

Examining the Impact of Real-World Evidence on Medical Product Development

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 :Unknown
  • Release Date :2019-04-05
  • Total pages :230
  • ISBN : 9780309488327
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Summary : 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.

Innovation in Clinical Trial Methodologies

Innovation in Clinical Trial Methodologies
  • Author : Peter Schueler
  • Publisher :Unknown
  • Release Date :2020-11-01
  • Total pages :202
  • ISBN : 9780323860062
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Summary : Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design. Considers multiple digital and virtual strategies Explores best practices, including the use of reduced patient involvement Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials

Clinical Trials Design in Operative and Non Operative Invasive Procedures

Clinical Trials Design in Operative and Non Operative Invasive Procedures
  • Author : Kamal M.F. Itani,Domenic J. Reda
  • Publisher :Unknown
  • Release Date :2017-05-16
  • Total pages :495
  • ISBN : 9783319538778
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Summary : The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists