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This updated edition of Painless Evidence-Based Medicine presents basic concepts and application of research statistics in simple and practical manner creating an introductory approach to the complex and technical subject of evidence-based medicine from experienced teachers.
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Seitenzahl: 256
Veröffentlichungsjahr: 2016
Cover
Title Page
Copyright
List of Contributors
Foreword to the First Edition
References
Foreword to the Second Edition
Preface
Reference
Chapter 1: Introduction
1.1 The definition of EBM
1.2 The three skills of EBM
1.3 Summary
References
Chapter 2: Evaluation of Articles on Therapy
2.1 Appraising directness
2.2 Appraising validity
2.3 Appraising the results
2.4 Assessing applicability
2.5 Individualizing the results
2.6 Sharing the decision
2.7 Summary
References
Chapter 3: Evaluation of Articles on Diagnosis
3.1 Appraising directness
3.2 Appraising validity
3.3 Appraising the results
3.7 Summary
References
Chapter 4: Evaluation of Articles on Harm
4.1 Appraising directness
4.2 Appraising validity
4.3 Appraising the results
4.4 Assessing applicability
4.5 Individualizing the results
4.6 Sharing the decision
4.7 Summary
References
Chapter 5: Evaluation of Articles on Prognosis
5.1 Appraising directness
5.2 Appraising validity
5.3 Appraising the results
5.4 Assessing applicability
5.5 Individualizing the results
5.6 Sharing the decision
5.7 Summary
References
Chapter 6: Evaluation of Systematic Reviews
6.1 Appraising directness
6.2 Appraising validity
6.3 Appraising the results
6.4 Assessing applicability
6.5 Individualizing the results
6.6 Sharing the decision
6.7 Summary
References
Chapter 7: Evaluation of Clinical Practice Guidelines
7.1 Appraising directness
7.2 Appraising validity
7.3 Appraising the results
7.4 Assessing applicability
7.5 Individualizing the recommendations
7.6 Sharing the decision
7.7 Summary
References
Chapter 8: Evaluation of Articles on Health Screening
8.1 Appraising directness
8.2 Appraising validity
8.3 Appraising the results
8.4 Assessing applicability
8.5 Individualizing the results
8.6 Sharing the decision
8.7 Summary
References
Chapter 9: Literature Searches
9.1 What are electronic databases?
9.2 The language of electronic databases
9.3 Steps in performing a literature search
9.4 Other ways to search
9.5 Summary
References
Index
End User License Agreement
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cover
Table of Contents
Foreword to the First Edition
Preface
Begin Reading
Chapter 1: Introduction
Figure 1.1 Cumulative number of MEDLINE citations containing the phrase “evidence- based” in the title or abstract
Chapter 2: Evaluation of Articles on Therapy
Figure 2.1 Survival curve of a hypothetical randomized controlled trial
Figure 2.2 Face table summarizing the effect of warfarin in a patient with atrial fibrillation but no valve disease, derived from the data in Tackle Box 2.4. Stroke goes down from 5 to 2%, but hemorrhage increases from 1 to 4%
Chapter 3: Evaluation of Articles on Diagnosis
Figure 3.1 Disease probability and thresholds of management
Figure 3.2 Bayes nomogram for estimating post-test probability.
Chapter 5: Evaluation of Articles on Prognosis
Figure 5.1 Survival rates over a 12-month follow-up period
Chapter 6: Evaluation of Systematic Reviews
Figure 6.1 Forest plot of a hypothetical systematic review evaluating a continuous outcome. Review: hypothetical example. Comparison: pill & exercise versus exercise alone. Outcome: mean weight loss in kilograms
Chapter 8: Evaluation of Articles on Health Screening
Figure 8.1 Health screening. Many (but not all) diseases are preceded by a clinical condition that is relatively silent (the precursor condition). This condition could be a risk factor for disease (e.g., hypertension) or an early disease that has not yet manifested (e.g., occult colon cancer). The goal of health screening is to detect this condition, then treat it to prevent disease, or at least its complications. To achieve this goal, health screening has three phases (the ovals), which include screening for the condition, confirming its presence, and starting early therapy, if necessary. Source: Adapted from Dans 2011.
[1]
Figure 8.2 Direct (A) and indirect (B) trials of the effectiveness of screening
Chapter 9: Literature Searches
Figure 9.1 Components of an electronic database of medical literature
Figure 9.2 The main features of the PubMed homepage
Figure 9.3 PubMed history feature, enabling previous searches to be combined. Note: Items found are counted in the next-to-last column
Figure 9.4 PubMed screen, displaying a portion of the MeSH tree
Figure 9.5 Using a MeSH term to search PubMed
Figure 9.6 Use of the PubMed history function to compare yield from a free text search (#5) and a MeSH search (#7)
Figure 9.7 PubMed Clinical Queries function, allowing articles to be searched for by category
Figure 9.8 “5S” hierarchy of information services. Source: Adapted from Haynes 2006.
[5]
Chapter 1: Introduction
Table 1.1 Components of our definition of EBM
Table 1.2 The three skills of EBM: how to acquire, appraise, and apply the evidence
Chapter 2: Evaluation of Articles on Therapy
Table 2.1 The problem of directness: differences in the types of questions asked by researchers and healthcare providers
Table 2.2 Baseline characteristics in a randomized trial assessing hospitalization rates with cardiac rehabilitation compared to usual care in patients with heart failure
[7]
Table 2.3 Ways of expressing effectiveness
Chapter 3: Evaluation of Articles on Diagnosis
Table 3.1 The problem of directness: potential differences in the types of questions asked by researchers and healthcare providers
Chapter 5: Evaluation of Articles on Prognosis
Table 5.1 Reporting prognosis in numbers
Chapter 6: Evaluation of Systematic Reviews
Table 6.1 Important validity criteria for assessing the quality of primary studies included in a systematic review
Table 6.2 Information required for individualization of results by type of research question
Chapter 8: Evaluation of Articles on Health Screening
Table 8.1 Potential harms from tests and treatments in a screening strategy
Table 8.2 Steps in individualizing results
Chapter 9: Literature Searches
Table 9.1 Methodology filters for various types of focused clinical question
Table 9.2 Examples of clinical questions, concepts, and how they may be prioritized
Edited by
Antonio L. Dans
Leonila F. Dans
Maria Asuncion A. Silvestre
Asia-Pacific Center for Evidence-Based Healthcare, Manila, Philippines
This edition first published 2017 © 2008, 2017 by John Wiley & Sons Ltd
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Library of Congress Cataloging-in-Publication Data
Names: Dans, Antonio L., editor. | Dans, Leonila F., editor. | Silvestre, Maria Asuncion A., editor.
Title: Painless evidence-based medicine / edited by Antonio L. Dans, Leonila F. Dans, Maria Asuncion A. Silvestre.
Description: Second edition. | Chichester, West Sussex ; Hoboken, NJ : John Wiley & Sons Inc., 2017. | Includes bibliographical references and index.
Identifiers: LCCN 2016035703| ISBN 9781119196242 (pbk.) | ISBN 9781119196259 (epub) | ISBN 9781119196266 (Adobe PDF)
Subjects: | MESH: Evidence-Based Medicine
Classification: LCC R723.7 | NLM WB 102.5 | DDC 610-dc23 LC record available at https://lccn.loc.gov/2016035703
A catalogue record for this book is available from the British Library.
Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books.
Cover image credit : shironosov/Gettyimages
Cover Designer: Wiley
Marc Evans Abat, MD
Center for Aging
The Medical City
Philippines
Jose M. Acuin, MD, MSc, MBA
Professor
Department of Otorhinolaryngology – Head and Neck Surgery
College of Medicine
De La Salle Health Sciences Institute
Philippines
Marissa M. Alejandria, MD, MSc
Professor
Department of Clinical Epidemiology
College of Medicine
University of the Philippines Manila
Philippines
Marion M. Aw, MBBS, MMed (Paeds), FRCPCH (UK), FAMS
Associate Professor
Department of Paediatrics
Yong Loo Lin School of Medicine
National University of Singapore
Singapore
Cynthia P. Cordero, MScPH, MMedStat
Professor
Department of Clinical Epidemiology
College of Medicine
University of the Philippines Manila
Philippines
Antonio L. Dans, MD, MSc
Professor
Department of Internal Medicine
Department of Clinical Epidemiology
College of Medicine
University of the Philippines Manila
Philippines
Leonila F. Dans, MD, MSc
Professor
Department of Pediatrics
Department of Clinical Epidemiology
College of Medicine
University of the Philippines Manila
Philippines
Irwani Ibrahim, MD, MPH
Emergency Medicine Department
National University Hospital
Singapore
Seng Gee Lim, MBBS, FRACP, FRCP, MD
Professor
Director of Hepatology
Division of Gastroenterology and Hepatology
National University Health System
Singapore
Aldrin B. Loyola, MD, MBAH
Associate Professor
Department of Internal Medicine
College of Medicine
University of the Philippines Manila
Philippines
Jacinto Blas V. Mantaring III, MD, MSc
Professor
Department of Pediatrics
Department of Clinical Epidemiology
College of Medicine
University of the Philippines Manila
Philippines
Shirley B. Ooi, MBBS(S'pore), FRCSEd(A&E), FAMS(Emerg Med)
Associate Professor
Emergency Medicine Department
National University Hospital
Singapore
Lia M. Palileo-Villanueva, MD, MSc
Associate Professor
College of Medicine
University of the Philippines Manila
Philippines
Maria Asuncion A. Silvestre, MD, FPSNbM
Asia Pacific Center for Evidence-Based Healthcare
Kalusugan ng Mag–Ina (Health of Mother and Child), Inc.
Philippines
Joey A. Tabula, MD
Department of Medicine
Philippine General Hospital
University of the Philippines Manila
Philippines
Nigel C.K. Tan, MBBS, FRCP (Edin), FAMS, MHPEd
Associate Professor
Senior Consultant Neurologist
National Neuroscience Institute
Singapore
Miriam Roxas Timonera, M.D.
Head of Medical Research Unit
Adventist Medical Center, Iligan City
Philippines
Bernadette A. Tumanan-Mendoza, MD, MSc, MHE
Department of Clinical Epidemiology
College of Medicine
University of the Philippines Manila
Philippines
Elenore Judy B. Uy, MD, MSc
Asia Pacific Center for Evidence-Based Healthcare
Philippines
Maria Vanessa Villarruz-Sulit, BSN, RN, MSc
Asia Pacific Center for Evidence-Based Healthcare
Philippines
No clinician would consider entering clinical practice without knowing the rudiments of history-taking and physical examination. Nor would clinicians consider independent practice without a basic understanding of how the drugs they prescribe act on their patients. Yet, traditionally, clinicians have started practice without an ability to understand evidence about how they should interpret what they find on history and physical examination, or the magnitude of the effects they might expect when they offer patients medication.
Evidence-based medicine (EBM) provides a remedy for this problem. The movement to teach clinicians to become effective users of medical literature began in the 1970s and evolved through the 1980s into a whole system for the delivery of clinical care. We needed a name for this new way of practice and the term “evidence-based medicine,” which first appeared in the medical literature in 1991,[1] proved extremely popular. Over the subsequent 16 years evidence-based medicine has evolved and now represents not only an approach to using the medical literature effectively, but a principled guide for the process of clinical decision-making.
Members of the general public are surprised, and often appalled, when they learn that most physicians remain unable to critically read an original research article or fully understand the results reported there. For the physician, inability to critically appraise a research study and grasp all that is implied in its findings limits their independence. The result is reliance on expert opinion, the practices of colleagues and on information from the pharmaceutical industry. But what is one to do if experts and colleagues disagree, or if one is mistrustful of the enthusiastic advice from a pharmaceutical industry representative?
This book represents the key to a world that provides the answer to that question, a world that has traditionally been closed to most practicing physicians: the world of original medical literature. Opening the door to this world is enormously empowering. No longer must one choose what to believe on the basis of which recommendation is backed by the most authority, or speaks with the loudest voice. The ability to differentiate high from low quality evidence and large treatment effects from small allows clinicians to make independent judgments about what is best for their patients. It also allows them to explain the impact of alternatives to the patients themselves, and thus to ensure that choices are consistent with patients' underlying values and preferences.
Ten years ago, experts and the official voices of the organizations to which they belonged consistently recommended long-term hormone replacement therapy (HRT) for post-menopausal women. These recommendations were made largely on the basis of observational studies suggesting that women taking HRT could expect large reductions to their risk of major cardiovascular events. Proponents of evidence-based medicine raised concerns about the wisdom of this strong advocacy of therapy for huge populations on the basis of the fundamentally weak methods of observational studies. Their voices were largely ignored, until randomized trials demonstrated that the results of the observational studies were incorrect. If HRT has any impact on cardiovascular disease at all, it is to increase its frequency.
Many clinical communities now endorse widespread population screening to prevent the occurrence of cancer and cardiovascular disease. Breast cancer screening for women as young as 40 years, colon cancer screening for entire populations, and treatment to improve lipid profiles even in very low risk patients are widely advocated. Many clinicians are unaware that to prolong a single life, hundreds of individuals must be screened for breast or colon cancer or treated with lipid profile-modifying agents for periods of up to a decade. The costs include anxiety as a result of the many false positive results, complications of invasive procedures such as lumpectomy or colonoscopy, side effects of treatment (including deaths as a result of a lipid-lowering agent now withdrawn from the market), and resource investment that, at least for some individuals, might be better allocated elsewhere. The point is not that the experts were uniformly wrong in suggesting that women consider HRT, nor that screening or treatment of low-risk individuals to modify their cancer or coronary risk is wrong. Rather, it is that clinicians should be aware there are important trade-offs in these decisions. If clinicians don't know the difference between an observational study and a randomized trial, or between a relative risk reduction and a risk difference, they are in no position to understand these trade-offs. If they are unable to understand the trade-offs, it is not possible for them to convey the possible benefits and risks to their patients, many of whom may, with a full understanding, decline screening or treatment.
This book provides the basic tools for the clinician to evaluate the strength of original studies, to understand their results and to apply those results in day-to-day clinical practice. I am delighted to inform the reader that its editors are not only brilliant teachers who have created a wonderful introductory text, but wonderful human beings. I met Tony and Inday Dans just about the time that our McMaster group was realizing that what we had been calling “critical appraisal” had evolved into a systematic approach to medical practice, a system of thinking about clinical care and clinical decision-making.
Inday and Tony had come to McMaster to train in clinical epidemiology – the science that underlies evidence-based medicine. I had the great pleasure of working with both these brilliant, enthusiastic, and critical young people. I was extremely fortunate that Tony chose me as one of his supervisors, and as a result we had the opportunity to work particularly closely together. It was not long before I discovered that I had the privilege of interacting with an extraordinary individual, exceptional even among the lively, intelligent, dedicated students who populated our Masters program. Tony was far more questioning than most students, and possessed a far deeper and more intense social conscience. To me, these qualities were very striking.
Since their days at McMaster, Inday and Tony have continued to demonstrate their high intelligence, tremendous initiative, extraordinary ability to question and explore issues at the deepest level, and their unusual and extremely admirable social conscience. Having a social conscience leads you to challenge existing power structures and vested interests. Doing so requires more than conscience: it requires courage. I have had the good fortune and great pleasure to interact with Inday and Tony in a variety of settings at quite regular intervals, and have as a result seen first-hand how their courage has led them to repeatedly challenge authority and power, acting in the interests of the Philippine people. To use the adjective preferred by young Canadians nowadays, their performance has been consistently awesome.
I will add one final anecdote about what makes Tony and Inday so special. Each year, we conduct a “how to teach evidence-based medicine” workshop at McMaster. In the last few years, Tony and Inday have participated in the workshop in the role of tutor trainees. Almost all participants in the workshop feel they learn a great deal, and take elements of what they have discovered back to their own teaching settings. But very few, and extremely few among the very experienced, make major innovations in their teaching as a result. Despite having run literally dozens of extremely successful workshops in the Philippines prior to their participation in the McMaster workshop, Inday and Tony took the key elements of the McMaster strategy and revamped their approach to their own workshops. The result has been a spectacular success, with Philippine participants reporting profoundly positive educational experiences. In the two decades in which I have participated in our workshop, I've never seen anyone make as good use of their experience with us. The message about Tony and Inday: a tremendous openness and ability to integrate what they've learned and apply in imaginative and perspicacious ways in their own setting.
One fortunate consequence of Inday and Tony's brilliant teaching – which makes the presentation of this book so vividly clear – is that it inspires others. About ten years ago Maria Asuncion (Mianne) Silvestre, a neonatologist, attended one of the Dans' workshops and emerged as an EBM enthusiast. She took on a teaching role and emerged as one of the most effective EBM facilitators in the Philippines. Her insights and experience have also contributed to the lucid presentations in this text.
We shall now take advantage of Inday, Tony, and Mianne's enormous experience of EBM and their imagination and brilliant teaching abilities in this wonderful book. The title “Painless EBM” captures the essence of their work. They have presented challenging concepts in simple, clear, and extremely appealing ways which make learning EBM painless and enjoyable. They have emphasized the last of the three pillars of the EBM approach: while the book tells you about validity and understanding the results, the focus is on applicability. What is the meaning of the evidence? How can you apply it in your own setting? How can you apply the evidence to patients with very different circumstances and varying values and preferences?
Increasingly, applying the literature to clinical practice does not mean a detailed reading of a large number of original studies. Rather, the clinician can recognize valid pre-appraised resources and differentiate them from poorly substantiated opinion. The book provides guides for assessing not only original studies of diagnosis and therapy, but also systematic reviews which summarize a number of such original studies. The ability to differentiate strong from weak literature reviews and to understand summaries of the magnitude of treatment effects is crucial for efficient evidence-based practice.
When a new pivotal study comes to light, evidence-based clinicians do not need to read it in detail to evaluate its significance or to decide how to use its results. Imagine that I am telling you about a recently conducted study reporting an apparently important treatment effect. I tell you: that the study was a randomized trial and that randomization was adequately concealed; that patients, caregivers, and those collecting and adjudicating outcome data were blind to whether patients received treatment or control interventions; that investigators successfully followed all patients who were randomized; and that, in the analysis, all patients were included in the groups to which they were randomized. Assuming that I am skilled in making these judgments, and am telling you the truth, you have all the information you need to judge the validity of the study. If I then provide you with a few crucial details of who was enrolled, how the interventions were administered, and the magnitude and precision of estimates of the impact of the intervention on all patient-relevant outcomes, you have everything you need to apply the results in clinical practice.
Synopses of individual studies which provide the crucial information needed to understand the appropriate strength of inference to apply the results are increasingly available, as are systematic reviews, and, to a lesser extent, high-quality evidence-based practice guidelines. Entire systems of knowledge based on evidence-based principles and textbooks of evidence-based medicine are beginning to arrive. The innovative electronic text UpToDate is an example of a resource that strives to be fully evidence-based and to provide guidance for most dilemmas that clinicians face in practice; UpToDate is effective in meeting both these aims.
When you, as a clinician, have read and digested the current text, you will have the tools to read and interpret synopses and systematic reviews and will be able to find such pearls in the rocky landscape of the current medical literature. In this text you will find case studies and examples directly relevant to your area of clinical practice. More importantly, you will find true-to-life examples of how to address the daily patient dilemmas you face more effectively. You will find clinical practice more satisfying and, most important, you will be more confident in providing your patients with optimal medical care. Finally, if you are interested in a deeper understanding of EBM, this book provides a stepping stone to a more comprehensive text that can provide knowledge and skills required for not only the practice, but also the teaching of EBM.[2]
It has been my privilege and joy to reflect on EBM in the context of this wonderful book, prepared by two of my dear friends and their outstanding colleague.
Gordon Guyatt, MDMcMaster University
[1] Evidence-Based Medicine Working Group (1992) Evidence-based medicine. A new approach to teaching the practice of medicine.
Journal of the American Medical Association.
,
268
(17), 2420–2425.
[2] Guyatt, G. and Rennie, D. (eds) (2002)
The Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice
, AMA Publications, Chicago, IL.
There is nothing more deceptive than an obvious fact
.
Arthur Conan Doyle, “The Boscombe Valley Mystery”
Over the course of my career, I have been encouraged by the decrease in “eminence-based” authoritarian medical teachers, for reputations can be deceiving! I have witnessed, in contrast, the steady but relentless increase in individuals who facilitate the learning of “evidence-based medicine.” This framework is exemplified in this splendid pocket-sized text by Antonio (Tony) and Leonila (Inday) Dans, Maria Asuncion Silvestre, and colleagues.
I have had the pleasure of working with and learning from Tony and Inday since 1991, when they came to Canada for training in clinical epidemiology. They quickly mastered the skills of not only challenging dogma but coming up with new ways of implementing solutions. They have long been interested in the teaching of clinical epidemiology and evidence-based medicine, and were founding members of the Clinical Epidemiology Research and Training Centre (CERTC) in the University of the Philippines, one of the first international training centers funded by the Rockefeller Foundation. This center has since produced many clinician graduates – such as the co-authors of this text.
Inday and Tony have grown into highly valued members of the editorial team of the Journal of Clinical Epidemiology (Elsevier). Bringing in fresh perspectives from the developing world, they have led the establishment of a substantive focus, viewing problems that clinicians may face globally from different vantage points. They have brought in tutorials and regional series on the challenges and tailored solutions to research and training in clinical epidemiology in low- and middle-income countries. Similarly, with clinicians in mind, in this book, learning of evidence-based medicine is framed around asking the relevant clinical question rather than around the usual approach of different study designs. This learning is viewed from different angles (from the perspective of both healthcare providers and their patients) and varying levels (ranging from elementary questions to systemic challenges).
What does painless evidence-based medicine mean to me? Painless evidence-based medicine can be achieved, and even the most complex of concepts mastered, if (i) it is appreciated for how important it is and (ii) learning the skills is made rewarding and (as their mentor and mine, David Sackett, would say) fun!
Importance: The cost of health care is increasing exponentially. Thus, evidence-based medicine is even more important as the basis for the needed tough decisions in times of scarce resources.1 Evidence is being published at ever increasing rates, not only in traditional journals but also in the gray literature and on social media. Thus, clinicians need to realize the importance of navigating this maze efficiently, not only for themselves but also for – and together with – their patients. As the authors point out, this requires three skill sets: acquisition, appraisal, and application of evidence.
