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Basic & Clinical Biostatistics introduces the medical student, researcher, or practitioner to the study of statistics applied to medicine and other disciplines in the health field. The authors, a statistician who is professor emeritus in a department of medicine and a practicing physician who participates in numerous clinical trials, have incorporated their experiences in medicine and statistics to develop a comprehensive text. The book covers the basics of biostatistics and quantitative methods in epidemiology and the clinical applications in evidence-based medicine and the decision-making methods. Particular emphasis is on study design and interpretation of results of research.

OBJECTIVE

Our primary objective is to provide the resources to help the reader become an informed user and consumer of statistics, and we have endeavored to make our presentation lively and interesting. This book should allow you to:

• Develop sound judgment about data applicable to clinical care.
• Read the clinical literature critically, understanding potential errors and fallacies contained therein, and apply confidently the results of medical studies to patient care.
• Interpret commonly used vital statistics and understand the ramifications of epidemiologic information for patient care and prevention of disease.
• Reach correct conclusions about diagnostic procedures and laboratory test results.
• Interpret manufacturers' information about drugs, instruments, and equipment.
• Evaluate study protocols and articles submitted for publication and actively participate in clinical research.
• Develop familiarity with well-known statistical software and interpret the computer output.

APPROACH & DISTINGUISHING FEATURES

We have attempted to keep the practitioner's interests, needs, and perspectives in mind. Thus, our approach embraces the following features:

• A genuine medical context is offered for the subject matter. After the introduction to different kinds of studies is presented in Chapter 2, subsequent chapters begin with several Presenting Problems—discussions of studies that have been published in the medical literature. These illustrate the methods discussed in the chapter and in some instances are continued through several chapters and in the exercises to develop a particular line of reasoning more fully.
• Actual data from the presenting problems are used to illustrate the statistical methods.
• A focus on concepts is accomplished by using computer programs to analyze data and by presenting statistical calculations only to illustrate the logic behind certain statistical methods.
• The importance of sample size (power analysis) is emphasized, and computer programs to estimate sample size are illustrated.
• Information is organized from the perspective of the research question being asked.
• Terms are defined within the relevant text, whenever practical, because biostatistics may be a new language to you. In addition, a glossary of statistical and epidemiologic terms is provided at the end of the book.
• A table of all symbols used in the book is provided on the inside back cover.
• A simple classification scheme of study designs used in clinical research is discussed (Chapter 2). We employ this scheme throughout the book as we discuss the presenting problems.
• Flowcharts are used to relate research questions to appropriate statistical methods (inside front cover and Appendix C).
• A step-by-step explanation of how to read the medical literature critically (Chapter 13)—a necessity for the modern health professional—is provided.
• Evidence-based medicine and decision making are addressed in a clinical context (Chapters 3 and 12). Clinicians will be called on increasingly to make decisions based on statistical information.
• The reference section is divided into two categories to facilitate the search for the sources of a presenting problem or for a text or an article on a specific topic.
• Numerous end-of-chapter exercises (Chapters 2 through 12) and their complete solutions (Appendix B) are provided.
• A posttest of multiple-choice questions (Chapter 13) similar to those used in course final examinations or licensure examinations is included.

SPECIAL FEATURES IN THIS EDITION

We made several important enhancements to the fourth edition.
To facilitate and increase learning, each chapter (except Chapter 1) contains a set of key concepts to orient the reader to the important ideas discussed in the chapter. The icon shown above marks the point in the chapter where the concept is discussed.

• In addition to the key concepts, we added a completely new chapter on survey research (Chapter 11) and expanded the discussion of logistic regression, the Cox model, and other multivariate statistical methods in Chapter 10.
• We updated many of the presenting problems and, through the generosity of the authors of these studies, have been able to use the actual data to illustrate the statistical methods and design issues.
• We continue to organize the chapters to reflect the way investigators ask research questions, as opposed to the traditional organization of texts based strictly on statistical methods. For instance, three chapters discuss how to analyze questions about means and proportions depending on the number of groups in the study: one, two, or more than two.
• Please refer to our Web page http://www.clinicalbiostatistics.com where we will list updates and other items of interest. You may also wish to take a look at the NCSS Web site http://www.ncss.com for new developments.

Beth Dawson, PhD
Robert G. Trapp, MD
March 2004

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