Ethical and Regulatory Aspects of Clinical Research

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Author :
Publisher :
ISBN 13 :
Total Pages : 532 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical and Regulatory Aspects of Clinical Research by : Ezekiel J. Emanuel

Download or read book Ethical and Regulatory Aspects of Clinical Research written by Ezekiel J. Emanuel and published by . This book was released on 2003 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professionals in need of such training and bioethicists will be interested.

Principles and Practice of Clinical Research

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Publisher : Elsevier
ISBN 13 : 0080489567
Total Pages : 447 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government

The CTSA Program at NIH

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Publisher : National Academies Press
ISBN 13 : 0309284740
Total Pages : 179 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis The CTSA Program at NIH by : Institute of Medicine

Download or read book The CTSA Program at NIH written by Institute of Medicine and published by National Academies Press. This book was released on 2013-10-09 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2006 the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) Program, recognizing the need for a new impetus to encourage clinical and translational research. At the time it was very difficult to translate basic and clinical research into clinical and community practice; making it difficult for individual patients and communities to receive its benefits. Since its creation the CTSA Program has expanded, with 61 sites spread across the nation's academic health centers and other institutions, hoping to provide catalysts and test beds for policies and practices that can benefit clinical and translation research organizations throughout the country. The NIH contracted with the Institute of Medicine (IOM) in 2012 to conduct a study to assess and provide recommendations on appropriateness of the CTSA Program's mission and strategic goals and whether changes were needed. The study was also address the implementation of the program by the National Center for Advancing Translational Sciences (NCATS) while exploring the CTSA's contributions in the acceleration of the development of new therapeutics. A 13-member committee was established to head this task; the committee had collective expertise in community outreach and engagement, public health and health policy, bioethics, education and training, pharmaceutical research and development, program evaluation, clinical and biomedical research, and child health research. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research is the result of investigations into previous program evaluations and assessments, open-session meetings and conference class, and the review of scientific literature. Overall, the committee believes that the CTSA Program is significant to the advancement of clinical and translational research through its contributions. The Program would benefit from a variety of revisions, however, to make it more efficient and effective.

Envisioning a Transformed Clinical Trials Enterprise in the United States

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Publisher : National Academies Press
ISBN 13 : 0309253187
Total Pages : 248 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Envisioning a Transformed Clinical Trials Enterprise in the United States by : Institute of Medicine

Download or read book Envisioning a Transformed Clinical Trials Enterprise in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Managing the NIH Bethesda Campus Capital Assets for Success in a Highly Competitive Global Biomedical Research Environment

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Publisher : National Academies Press
ISBN 13 : 0309494362
Total Pages : 181 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Managing the NIH Bethesda Campus Capital Assets for Success in a Highly Competitive Global Biomedical Research Environment by : National Academies of Sciences, Engineering, and Medicine

Download or read book Managing the NIH Bethesda Campus Capital Assets for Success in a Highly Competitive Global Biomedical Research Environment written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-11-02 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research. Founded in the late 1870s, NIH has produced extraordinary advances in the treatment of common and rare diseases and leads the world in biomedical research. It is a critical national resource that plays an important role in supporting national security. The 310-acre Bethesda campus supports some 20,000 employees and contractors, and it contains more than 12 million square feet of facilities divided amongst nearly 100 buildings, including the largest dedicated research hospital in the world. The Bethesda campus supports some of the most sophisticated and groundbreaking biomedical research in the world. However, while some new state-of-the-art buildings have been constructed in recent years, essential maintenance for many facilities and the campus overall has been consistently deferred for many years. The deteriorating condition of NIH's built environment is now putting its ability to fulfill its mission at substantial risk. Managing the NIH Bethesda Campus's Capital Assets for Success in a Highly Competitive Global Biomedical Research Environment identifies the facilities in greatest need of repair on the Bethesda campus and evaluates cost estimates to determine what investment is needed for the NIH to successfully accomplish its mission going forward.

Clinical Data as the Basic Staple of Health Learning

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Publisher : National Academies Press
ISBN 13 : 0309120608
Total Pages : 338 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Clinical Data as the Basic Staple of Health Learning by : Institute of Medicine

Download or read book Clinical Data as the Basic Staple of Health Learning written by Institute of Medicine and published by National Academies Press. This book was released on 2011-01-14 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful development of clinical data as an engine for knowledge generation has the potential to transform health and health care in America. As part of its Learning Health System Series, the Roundtable on Value & Science-Driven Health Care hosted a workshop to discuss expanding the access to and use of clinical data as a foundation for care improvement.

Your Guide to the Clinical Center

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Publisher :
ISBN 13 :
Total Pages : 2 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Your Guide to the Clinical Center by :

Download or read book Your Guide to the Clinical Center written by and published by . This book was released on 1989 with total page 2 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Transforming Clinical Research in the United States

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Publisher : National Academies Press
ISBN 13 : 0309163358
Total Pages : 151 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Transforming Clinical Research in the United States by : Institute of Medicine

Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

The Cleveland Clinic Way: Lessons in Excellence from One of the World's Leading Health Care Organizations VIDEO ENHANCED EBOOK

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Author :
Publisher : McGraw Hill Professional
ISBN 13 : 0071839348
Total Pages : 273 pages
Book Rating : 4.0/5 (718 download)

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Book Synopsis The Cleveland Clinic Way: Lessons in Excellence from One of the World's Leading Health Care Organizations VIDEO ENHANCED EBOOK by : Toby Cosgrove

Download or read book The Cleveland Clinic Way: Lessons in Excellence from One of the World's Leading Health Care Organizations VIDEO ENHANCED EBOOK written by Toby Cosgrove and published by McGraw Hill Professional. This book was released on 2014-01-24 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the future. Join the revolution. Transform your organization the Cleveland Clinic way. "One of the best healthcare systems in the world." President Barack Obama American healthcare is in crisis. It doesn't have to be. There's a revolution going on right now. On the frontiers of medicine, some doctors have developed an approach for treating people that is more effective, more humane, and more affordable. It's an approach to healthcare that has captured the attention of the media and business elite--and the President of the United States. It's all happening at Cleveland Clinic, one of the most innovative, forward-looking medical institutions in the nation. In this groundbreaking book, the man who leads this global organization, Toby Cosgrove, MD, reveals how the Clinic works so well and argues persuasively for why it should be the model for the nation. He details how Cleveland Clinic focuses on the eight key trends that are shaping the future of medicine. Readers will learn: Why group practices provide not only better--but cheaper--care Why collaborative medicine is more effective How big data can be harnessed to improve the quality of care and lower costs How cooperative practices can be the wellspring of innovation Why empathy is crucial to better patient outcomes Why wellness of both mind and body depends on healthcare, not sickcare How care is best provided in different settings for greater comfort and value How tailor-made care treats a person instead of a disease This enhanced eBook includes 8 videos that include interviews with the doctors and executives who helped shape the Cleveland Clinic’s successful strategy. It also includes visuals of patients/doctor interactions and the hospital’s facilities. At its core is Cleveland Clinic's emphasis on patient care and patient experience. A refreshingly positive and practical vision of healthcare, The Cleveland Clinic Way is essential reading for healthcare and business executives, medical professionals, industry analysts, and policymakers. It gives leaders lessons they can apply to their own organizations to achieve results and empowers average Americans to make more informed healthcare decisions. PRAISE FOR THE CLEVELAND CLINIC WAY "A brilliant doctor and leader lays out practical and thought-provoking prescriptions for America's healthcare future. A must-read." -- Jack Welch, former Chairman and CEO of General Electric Company "The Cleveland Clinic Way is what the healthcare system in this country needs: honesty about the challenges, optimism about our ability to address them, and a focus on solutions. A must-read for healthcare leaders, it's written in clear, inclusive language that makes it just as valuable for the rest of us." -- John Chambers, Chairman and CEO of Cisco "A pioneer in American healthcare, Toby Cosgrove shows just how the diligence and innovative thinking behind Cleveland Clinic has helped solve fundamental problems most other places barely touch. There are lessons here for everyone--patient, physician, and policymaker alike." -- Atul Gawande, MD, professor at Harvard Medical School and bestselling author of The Checklist Manifesto "Toby Cosgrove frames the eight important trends that will transform the U.S. healthcare system. The Cleveland Clinic Way is a good road map for those who want to make the U.S. healthcare system better." -- Jeffrey Immelt, Chairman and CEO of General Electric Company

How the Clinic Made Gender

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Author :
Publisher : University of Chicago Press
ISBN 13 : 022657346X
Total Pages : 341 pages
Book Rating : 4.2/5 (265 download)

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Book Synopsis How the Clinic Made Gender by : Sandra Eder

Download or read book How the Clinic Made Gender written by Sandra Eder and published by University of Chicago Press. This book was released on 2022-06-07 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: An eye-opening exploration of the medical origins of gender in modern US history. Today, a world without “gender” is hard to imagine. Gender is at the center of contentious political and social debates, shapes policy decisions, and informs our everyday lives. Its formulation, however, is lesser known: Gender was first used in clinical practice. This book tells the story of the invention of gender in American medicine, detailing how it was shaped by mid-twentieth-century American notions of culture, personality, and social engineering. Sandra Eder shows how the concept of gender transformed from a pragmatic tool in the sex assignment of children with intersex traits in the 1950s to an essential category in clinics for transgender individuals in the 1960s. Following gender outside the clinic, she reconstructs the variable ways feminists integrated gender into their theories and practices in the 1970s. The process by which ideas about gender became medicalized, enforced, and popularized was messy, and the route by which gender came to be understood and applied through the treatment of patients with intersex traits was fraught and contested. In historicizing the emergence of the sex/gender binary, Eder reveals the role of medical practice in developing a transformative idea and the interdependence between practice and wider social norms that inform the attitudes of physicians and researchers. She shows that ideas like gender can take on a life of their own and may be used to question the normative perceptions they were based on. Illuminating and deeply researched, the book closes a notable gap in the history of gender and will inspire current debates on the relationship between social norms and medical practice.

Interventional Urology

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Publisher : Springer Nature
ISBN 13 : 3030735656
Total Pages : 567 pages
Book Rating : 4.0/5 (37 download)

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Book Synopsis Interventional Urology by : Ardeshir R. Rastinehad

Download or read book Interventional Urology written by Ardeshir R. Rastinehad and published by Springer Nature. This book was released on 2021-11-17 with total page 567 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updated text provides a concise yet comprehensive and state-of-the-art review of evolving techniques in the new and exciting subspecialty of interventional urology. Significant advances in imaging technologies, diagnostic tools, fusion navigation, and minimally invasive image-guided therapies such as focal ablative therapies have expanded the interventional urologists’ clinical toolkit over the past decade. Organized by organ system with subtopics covering imaging technologies, interventional techniques, recipes for successful practice, pitfalls to shorten the learning curves for new technologies, and clinical outcomes for the vast variety of interventional urologic procedures, this second edition includes many more medical images as well as helpful graphics and reference illustrations. The second edition of Interventional Urology serves as a valuable resource for clinicians, interventional urologists, interventional radiologists, interventional oncologists, urologic oncologists, as well as scientists, researchers, students, and residents with an interest in interventional urology.

Beyond the HIPAA Privacy Rule

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Publisher : National Academies Press
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Health Century

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Publisher : New York : Doubleday
ISBN 13 :
Total Pages : 346 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis The Health Century by : Edward Shorter

Download or read book The Health Century written by Edward Shorter and published by New York : Doubleday. This book was released on 1987 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: Companion volume to PBS television series. Presents the moving human drama behind the scientific miracles most pertinent to all of our lives.

Clinical Center of the National Institutes of Health

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Publisher :
ISBN 13 :
Total Pages : 16 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Clinical Center of the National Institutes of Health by : National Institutes of Health (U.S.). Clinical Center

Download or read book Clinical Center of the National Institutes of Health written by National Institutes of Health (U.S.). Clinical Center and published by . This book was released on 1970 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Handbook for Patients at the Clinical Center

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Author :
Publisher :
ISBN 13 :
Total Pages : 16 pages
Book Rating : 4.:/5 ( download)

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Book Synopsis Handbook for Patients at the Clinical Center by : National Institutes of Health (U.S.). Clinical Center

Download or read book Handbook for Patients at the Clinical Center written by National Institutes of Health (U.S.). Clinical Center and published by . This book was released on 1953 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Management Lessons from the Mayo Clinic (PB)

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Publisher : McGraw Hill Professional
ISBN 13 : 0071590749
Total Pages : 310 pages
Book Rating : 4.0/5 (715 download)

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Book Synopsis Management Lessons from the Mayo Clinic (PB) by : Leonard L. Berry

Download or read book Management Lessons from the Mayo Clinic (PB) written by Leonard L. Berry and published by McGraw Hill Professional. This book was released on 2008-05-31 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Management Lessons from Mayo Clinic reveals for the first time how this complex service organization fosters a culture that exceeds customer expectations and earns deep loyalty from both customers and employees. Service business authority Leonard Berry and Mayo Clinic marketing administrator Kent Seltman explain how the Clinic implements and maintains its strategy, adheres to its management system, executes its care model, and embraces new knowledge - invaluable lessons for managers and service providers of all industries. Drs. Berry and Seltman had the rare opportunity to study Mayo Clinic's service culture and systems from the inside by conducting personal interviews with leaders, clinicians, staff, and patients, as well as observing hundreds of clinician-patient interactions. The result is a book about how the Clinic's business concept produces stellar clinical results, organizational efficiency, and interpersonal service. By examining the operating principles that guide every management decision at this legendary healthcare institution, the authors Demonstrate how a great service brand evolves from the core values that nourish and protect it Extrapolate instructive business lessons that apply outside healthcare Illustrate the benefits of pooling talent and encouraging teamwork Relate historical events and perspectives to the present-day Mayo Clinic Share inspiring stories from staff and patients An innovative analysis of this exemplary institution, Management Lessons from Mayo Clinic presents a proven prescription for creating sustainable service excellence in any organization.

Smith's Patient Centered Interviewing: An Evidence-Based Method, Third Edition

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Author :
Publisher : McGraw Hill Professional
ISBN 13 : 0071805850
Total Pages : 349 pages
Book Rating : 4.0/5 (718 download)

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Book Synopsis Smith's Patient Centered Interviewing: An Evidence-Based Method, Third Edition by : Auguste H. Fortin

Download or read book Smith's Patient Centered Interviewing: An Evidence-Based Method, Third Edition written by Auguste H. Fortin and published by McGraw Hill Professional. This book was released on 2012-05-11 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive, evidence-based introduction to the principles and practices of patient communication in a clinical setting Endorsed by the American Academy on Communication for Healthcare Updated and expanded by a multidisciplinary team of medical experts, Smith’s Patient-Centered Interviewing, Third Edition presents a step-by-step methodology for mastering every aspect of the medical interview. You will learn how to confidently obtain from patients accurate biomedical facts, as well as critical personal, social, and emotional information, allowing you to make precise diagnoses, develop effective treatment plans, and forge strong clinician-patient relationships. The most evidence-based guide available on this topic, Smith’s Patient-Centered Interviewing applies the proven 5-Step approach, which integrates patient- and clinician-centered skills to improve effectiveness without adding extra time to the interview’s duration. Smith’s Patient-Centered Interviewing covers everything from patient-centered and clinician-centered interviewing skills, such as: Patient education Motivating for behavior change Breaking bad news Managing different personality styles Increasing personal awareness in mindful practice Nonverbal communication Using computers in the exam room Reporting and presenting evaluations Companion video and teaching supplement are available online. Read details inside the book.