Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide PDF Download

Author: Agency for Health Care Research and Quality (U.S.)
Publisher: Government Printing Office
ISBN: 1587634236
Category : Medical
Languages : en
Pages : 236

View

Book Description
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)

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309138361
Category : Medical
Languages : en
Pages : 252

View

Book Description
Clinical research presents health care providers with information on the natural history and clinical presentations of disease as well as diagnostic and treatment options. In today's healthcare system, patients, physicians, clinicians and family caregivers often lack the sufficient scientific data and evidence they need to determine the best course of treatment for the patients' medical conditions. Initial National Priorities for Comparative Effectiveness Research(CER) is designed to fill this knowledge gap by assisting patients and healthcare providers across diverse settings in making more informed decisions. In this 2009 report, the Institute of Medicine's Committee on Comparative Effectiveness Research Prioritization establishes a working definition of CER, develops a priority list of research topics, and identifies the necessary requirements to support a robust and sustainable CER enterprise. As part of the 2009 American Recovery and Reinvestment Act, Congress appropriated $1.1 billion in federal support of CER, reflecting legislators' belief that better decisions about the use of health care could improve the public's health and reduce the cost of care. The Committee on Comparative Effectiveness Research Prioritization was successful in preparing a list 100 top priority CER topics and 10 recommendations for best practices in the field.

Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385

View

Book Description
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: David A. Richards
Publisher: Routledge
ISBN: 1134470568
Category : Medical
Languages : en
Pages : 444

View

Book Description
Health and human services currently face a series of challenges – such as aging populations, chronic diseases and new endemics – that require highly complex responses, and take place in multiple care environments including acute medicine, chronic care facilities and the community. Accordingly, most modern health care interventions are now seen as ‘complex interventions’ – activities that contain a number of component parts with the potential for interactions between them which, when applied to the intended target population, produce a range of possible and variable outcomes. This in turn requires methodological developments that also take into account changing values and attitudes related to the situation of patients’ receiving health care. The first book to place complex interventions within a coherent system of research enquiry, this work is designed to help researchers understand the research processes involved at each stage of developing, testing, evaluating and implementing complex interventions, and assist them to integrate methodological activities to produce secure, evidence-based health care interventions. It begins with conceptual chapters which set out the complex interventions framework, discuss the interrelation between knowledge development and evidence, and explore how mixed methods research contributes to improved health. Structured around the influential UK Medical Research Council guidance for use of complex interventions, four sections, each comprised of bite-sized chapters written by multidisciplinary experts in the area, focus on: - Developing complex interventions - Assessing the feasibility of complex interventions and piloting them - Evaluating complex interventions - Implementing complex interventions. Accessible to students and researchers grappling with complex interventions, each substantive chapter includes an introduction, bulleted learning objectives, clinical examples, a summary and further reading. The perspectives of various stakeholders, including patients, families and professionals, are discussed throughout as are the economic and ethical implications of methods. A vital companion for health research, this book is suitable for readers from multidisciplinary disciplines such as medical, nursing, public health, health services research, human services and allied healthcare backgrounds.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309164257
Category : Medical
Languages : en
Pages : 267

View

Book Description
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.

Author: Constantine Gatsonis
Publisher: CRC Press
ISBN: 1351659456
Category : Mathematics
Languages : en
Pages : 634

View

Book Description
Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that will aid patients, clinicians, purchasers, and health policy makers in making informed decisions at both the individual and population levels. CER encompasses a very broad range of types of studies—experimental, observational, prospective, retrospective, and research synthesis. This volume covers the main areas of quantitative methodology for the design and analysis of CER studies. The volume has four major sections—causal inference; clinical trials; research synthesis; and specialized topics. The audience includes CER methodologists, quantitative-trained researchers interested in CER, and graduate students in statistics, epidemiology, and health services and outcomes research. The book assumes a masters-level course in regression analysis and familiarity with clinical research.

Author: Brian L. Strom
Publisher: John Wiley & Sons
ISBN: 1119413419
Category : Medical
Languages : en
Pages : 1220

View

Book Description
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.

Author: Rifat Latifi
Publisher: Springer Nature
ISBN: 3030569179
Category : Medical
Languages : en
Pages : 493

View

Book Description
Telemedicine and telehealth have consistently been shown to be effective for remote areas or limited-resource locations, regular medical and surgical practice, primary care, second opinion, extreme conditions, major crises, and disaster management. The aim of this book is to bring all aspects of telemedicine and e-health to the reader, in a simple, make-sense approach, in one tome. The book is structured in four parts with 29 chapters written by the best experts in the field from around the world, including clinicians, scientists, and administrators of telemedicine programs. Part I deals with basic principles of telemedicine and telepresence. Historical journeys of telemedicine and strategies, building sustainable telemedicine and telehealth programs in the United States and in the Balkans, as well as incorporation of telemedicine in the current ongoing pandemic COVID-19 are well described and are must read. Current technological developments, rules and regulations, legal and business aspects and consent are also addressed. Part II describes strategies for building sustainable telemedicine and telehealth programs. Telehealth patient portals and public-private partnership modes of technology, as well the role of international telemedicine and how to make it work, are valuable chapters of great significance. Part III describes outcomes-based evidence clinical applications of telemedicine in trauma, burns, intensive care, pediatric care, psychiatry, and stroke. Finally, one important chapter for the readers is the telemedicine for prison and jail population. The final part, Part IV depicts surgical telementoring and teleproctoring, a chapter written by 18 various surgical experts, a true gem for the readers. The book ends with promises and hurdles of telemedicine in austere conditions. Telemedicine, Telehealth and Telepresence serves as a valuable resource that focuses on providing patients care from a distance using store and forward technology to live actual performance of operations at a distance.Chapters 1, 6, 12 and 17 are available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

Author: Carol M. Ashton
Publisher:
ISBN: 019996856X
Category : History
Languages : en
Pages : 305

View

Book Description
Comparative Effectiveness Research: Evidence, Medicine, and Policy provides the first complete account of how — and why — the federal government decided to make comparative effectiveness research (CER) an important feature of health reform and the Affordable Care Act of 2010.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309372852
Category : Medical
Languages : en
Pages : 183

View

Book Description
Interprofessional teamwork and collaborative practice are emerging as key elements of efficient and productive work in promoting health and treating patients. The vision for these collaborations is one where different health and/or social professionals share a team identity and work closely together to solve problems and improve delivery of care. Although the value of interprofessional education (IPE) has been embraced around the world - particularly for its impact on learning - many in leadership positions have questioned how IPE affects patent, population, and health system outcomes. This question cannot be fully answered without well-designed studies, and these studies cannot be conducted without an understanding of the methods and measurements needed to conduct such an analysis. This Institute of Medicine report examines ways to measure the impacts of IPE on collaborative practice and health and system outcomes. According to this report, it is possible to link the learning process with downstream person or population directed outcomes through thoughtful, well-designed studies of the association between IPE and collaborative behavior. Measuring the Impact of Interprofessional Education on Collaborative Practice and Patient Outcomes describes the research needed to strengthen the evidence base for IPE outcomes. Additionally, this report presents a conceptual model for evaluating IPE that could be adapted to particular settings in which it is applied. Measuring the Impact of Interprofessional Education on Collaborative Practice and Patient Outcomes addresses the current lack of broadly applicable measures of collaborative behavior and makes recommendations for resource commitments from interprofessional stakeholders, funders, and policy makers to advance the study of IPE.