How to do clinical practice research: a new book and a new series in the Journal of Clinical Epidemiology☆

Article Outline

• 1. Introduction
• 2. Why this book?
• 3. Who are we?
• 4. A word about personal pronouns and “private stories”
• 5. Play (with) our CD
• 6. Visit our Web site
• References
• Copyright

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1. Introduction 

Our new book, Clinical Epidemiology: How to Do Clinical Practice Research, is about designing and conducting practical research in clinical settings. We're grateful for the opportunity to provide some of the book's contents for readers of the Journal of Clinical Epidemiology, and look forward to your feedback. This essay will provide the background for the book and the series of selected chapters presented in this issue of JCE.

Some readers may be familiar with the first edition (black cover) or second edition (red cover) of Clinical Epidemiology. They were written for “users” of clinical research, and the subtitle for those editions was A Basic Science for Clinical Medicine. In the third edition, the subtitle is different, How to Do Clinical Practice Research, signaling a distinct change of focus: people who wish to not only understand what clinical research is about but also create new clinical knowledge themselves, as principal investigators. If this is your current or future career plan, this book is written for you.

We've written Clinical Epidemiology: How to Do Clinical Practice Research for investigators at any stage of their careers, from beginning students to seasoned scientists. It is about how to find answers to questions about such matters as the prevention and treatment, diagnosis, prognosis, and cause of health care problems; the measurement of health status and quality of life; and the effect of innovations in health services. Each of these broad questions contains an array of finer questions. For example, questions about a health care intervention include examining whether such intervention does more good than harm under relatively ideal circumstances (efficacy: can it work?), whether it works under “real world” conditions (effectiveness: does it work?), whether it is good value for money and other resources (cost-effectiveness: is it worth it?), and how to transfer sound research findings about an intervention into effective care for individuals and communities (translation: is it translatable?). Similarly, additional questions about diagnostic tests include the extent to which a test result increases or decreases the probability that the target condition is present, and what are the consequences of diagnostic errors. And so on.

We've also included chapters about how to ask researchable questions, how to determine the burden of disease, how to prepare a protocol for funding, how to prepare reports for publication and respond to reviewers' comments, and how to deal with the media. It is these latter chapters that we will serialize in JCE, beginning in this issue with how to ask questions.

Our book isn't about biostatistics. We've pitched the mathematical–statistical level at that of a smart person who has passed high school algebra. We've done this for two reasons. First, we think that the major methodological challenges in clinical practice research have to do with preventing bias, not with performing statistical analyses. Second, we think it's vital to work with a statistician coinvestigator rather than try to master and apply modern statistical techniques yourself (unless you are already a statistician!). For biostatisticians who might otherwise find this book useful, we apologize in advance for any oversimplified statistical bits.

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2. Why this book? 

This question has several answers. The simple one is that we enjoy what we do as clinical researchers and take pleasure in teaching what we do to anyone who is interested. A more complex answer is that we are trying to fill the gap between superficial cookbooks and the “counsels of perfection” that tell readers what they must do to achieve methodological purity. The former neglect key issues at the clinical–methodological interface, and the latter fail to elucidate the rough-and-tumble practicalities of doing clinical practice research. We propose to take you behind the pretty protocols and fastidious final reports to convey the often wrenching, sometimes comical, and usually manageable challenges that you will confront as you design, conduct, analyze, and interpret clinical practice research. Along the way, we'll expose some of the politics of doing research, several ridiculous situations we got into and learned how to get out of, regrets we've had, and research projects that turned out better than we had any right to expect. It is the lessons we learned in getting into and out of these methodological pickles that distinguishes this book from the research methods book that was to have accompanied the first edition of this one. Finally, the four of us delight in the fun and learning of joint authorship. Our publisher's plea for a third edition spanned the period in which the practice of clinical epidemiology evolved into evidence-based medicine (EBM), and different combinations of us authored different texts in that new discipline [1], [2], [3], [4]. The need for a practical book on how to generate the “E” for “EBM” gave us a chance to get back together, and we gleefully seized that opportunity.

An underlying theme in our book is that doing clinical practice research is like shooting the rapids in a canoe. If you want to stay afloat without damaging your canoe, you need to learn how to anticipate trouble, to change your course in an instant when necessary, and to keep your sights on your ultimate goal, without worrying too much about pure paddle strokes or staying dry. To do this you'll need a deeper and more practical understanding of research methods than you can get by memorizing a printed page. You'll need to learn how to preserve the original intent of your investigation when confronted by barriers that preclude conducting your investigation precisely as you planned it. Better still, by working alongside us as we learned our lessons, you can design studies that will be less likely to stray into troubled waters in the first place, and less likely to capsize when they do.

To help you learn this blending of the science and art of research, we invite you to accompany us through the planning and execution of our own studies. Some of them happened when we were just beginning to learn how to paddle our own canoes; others are currently being planned (and teaching us some new strokes!). We provide scenarios describing the clinical stimulus and circumstances that led us to generate the questions we asked, show you what we planned to do, describe what happened, tell you how we coped with problems that arose, and admit what we would have done differently if we had a chance to do it all over again. We are the first to acknowledge that this won't substitute for you getting your own paddle in the water on your own projects. Nonetheless, we're convinced that joining us will provide you with a practical approach to designing and carrying out your own projects that you can't get from studying research methods in isolation, or from reading the fancified (and often fanciful) accounts of other people's research.

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3. Who are we? 

We are clinical epidemiologists, those odd folks with one foot in clinical care and the other in clinical practice research. As clinical epidemiologists, we apply a wide array of scientific principles, strategies, and tactics to answer questions about health and health care, especially the latter. The principles we use are drawn most often from the discipline of epidemiology—but we purloin research principles from, and collaborate with, colleagues from any methodologically oriented, scientifically based, discipline—statistics, psychology, the social sciences, economics, health policy, health informatics, and beyond.

We believe that bridging research and clinical practice, by being qualified and maintaining competence in both, has important advantages for the inspiration, relevance, and feasibility of the projects we undertake. Many of the best questions we have pursued come from our interactions (and failures!) with patients at the bedside and in the clinic, coupled with our understanding of what constitutes a researchable question. But we make no claim that trying to be competent in both research and clinical practice is either necessary or sufficient for conducting applied clinical research. Indeed, “big league” clinical research these days is very much a team sport, requiring people with many types of skills, including experts in research design, measurement, statistics, the clinical problem of interest, and, increasingly, the social sciences. We are intent on using sound research principles, tempered with practicality, to find the best answers to “real world” questions about clinical practice and health care.

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4. A word about personal pronouns and “private stories” 

When we began writing this book, we discussed how we would address you, the reader, when describing our work and views. We decided that we would use “we” and “us” and “our” when we mean the lot of us or when we mean you and us together; “I” and “me” and “mine” when one of us is describing work and thoughts that belong more or less uniquely to one of us (thus, the lead author of each chapter is identified); “you” when we would like you to try something yourself (and sometimes when we're just being preachy…); and “they” when talking about other people's research or principles. Our intention in using “I” is to be clear when we express our personal opinions. (Surprise! There isn't universal agreement on research tactics.) We'll switch to “we” when we want to change the perspective to tactics we all agree on or when describing activities we have done together or with others.

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5. Play (with) our CD 

The book includes a searchable CD of its entire contents for those of you who enjoy electronic access, or prefer lugging portable computers rather than books.

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6. Visit our Web site 

We also invite you to visit our book's Web site at http://hiru.mcmaster.ca/CLEP3. There, you will be able to let us know what you think of the book, ask questions, suggest corrections or improvements, find chapter updates, and learn how we and others are using the book in teaching clinical practice research. All welcome!

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References 

1. Sackett DL, Straus S, Richardson SR, Rosenberg W, Haynes RB. Evidence-based medicine: how to practice and teach EBM. 2nd ed. London: Churchill Livingstone; 2000;
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2. Straus S, Richardson SR, Glasziou P, Haynes RB. Evidence-based medicine: how to practice and teach EBM. 3rd ed. London: Churchill Livingstone; 2005;
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3. In:  Guyatt GH,  Rennie D editor. Users' guides to the medical literature: a manual for evidence based clinical practice. Chicago: AMA Press; 2002;
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4. In:  Guyatt GH,  Rennie D editor. Users' guides to the medical literature: the essentials of evidence-based clinical practice. Chicago: AMA Press; 2002;
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