This book has been developed to help medical students, physicians and other health professionals improve their own clinical research and, ultimately, to enhance patient care. Specifically, it is designed to help these audiences probe the increasingly complex and varied medical/scientific literature for knowledge to improve patient care and to guide efforts at their own research. It is based on a highly regarded and popular lecture series on research methodology, with particular emphasis on issues affecting clinical research, that the editors designed and have offered for 21 years to more than 1,000 members of the academic medical communities of Weill Cornell Medical College and the State University of New York (SUNY) Downstate Medical Center. The book spans the entire research process, beginning with the conception of the research problem to publication of findings. The need for such a book has become increasingly clear to us during many years of conducting a program of training and research in cardiovascular diseases and in our general teaching of research methodology to clinicians. Though agreement on the fundamental principles of scientific research has existed for more than a century and may be considered to have originated with the studies of Paré, the application of these principles has changed over time. The precision required in defining study populations and in detailing methodologies (and their deficiencies) is continually increasing. In addition, a bewildering arsenal of statistical tools has developed (and continues to grow) to identify and define the magnitude and consistency of relationships. Simultaneously, acceptable formats for communicating scientific data have changed in response to parallel changes in the world at large, and under the pressure of an "information explosion" which mandates succinctness and clarity. That said, there are, however, few if any books on the market that comprehensively and concisely present these concepts in a manner that is relevant and meaningful to a broad clinical medical community. This text is designed to resolve this deficiency by combining theory and practical application to familiarize the reader with the logic of research design and hypothesis construction, the fundamentals of writing a protocol or other research proposal (including ethical concerns), the logic and techniques of data collection and statistical analysis, and the requirements for documentation and data recording. This book also aims to clarify guidelines for assembling and interpreting results, writing scientific papers, and publishing studies. Its authors include prominent medical scientists and methodologists who have extensive personal experience in biomedical investigation and in teaching various key aspects of research methodology to medical students, physicians and other health professionals. We expect that this text will serve as a vital resource for individuals performing or attempting to understand and assimilate research. Unique aspects of the book include: Comprehensive presentation of fundamental methodological issues critical to initiating a biomedical study (e.g., research problem specification and evaluation, hypothesis construction, selection of appropriate study designs, protocol development)Emphasis on the role and structure of the scientific hypothesis (reinforced throughout the various chapters) in informing methods and statistical analysis plan, and in guiding data interpretation.Integration of theory and examples to promote concept acquisition and practical applicationLanguage and style that are clear and meaningful for a general medical audience Take-home points provide highlights of each chapter Unique aspects of the book include: Comprehensive presentation of fundamental methodological issues critical to initiating a biomedical study (e.g., research problem specification and evaluation, hypothesis construction, selection of appropriate study designs, protocol development)Emphasis on the role and structure of the scientific hypothesis (reinforced throughout the various chapters) in informing methods and statistical analysis plan, and in guiding data interpretation.Integration of theory and examples to promote concept acquisition and practical applicationLanguage and style that are clear and meaningful for a general medical audience Take-home points provide highlights of each chapter