Clinical Research Methods for Surgeons

With his keen analytical mind and penchant for organization, Charles Darwin would have made an excellent clinical investigator. Unfortunately for surgery, his early exposure at Edinburgh to the brutality of operations in 1825 convinced him to reject his father’s plan for his career and pursue his interest in nature. His subsequent observations of how environmental pressures shaped the development of new species provided the essential mechanism to explain evolution and the disappearance of those species that failed to adapt. Today, surgeons face the same reality as new technology, progressive regulation by government and payers, medico-legal risks, and public demands for proof of performance force changes in behavior that our predecessors never imagined. We know that surgeons have always prided themselves on accurate documentation of their results, including their complications and deaths, but observational studies involving a single surgeon or institution have given way to demands for controlled interventional trials despite the inherent difficulty of studying surgical patients by randomized, blinded techniques. That is why this book is so timely and important. In a logical and comprehensive approach, the authors have assembled a group of experienced clinical scientists who can demonstrate the rich variety of techniques in epidemiology and statistics for reviewing existing publications, structuring a clinical study, and analyzing the resulting data.

Clinical Research Methods for Surgeons is a comprehensive guide for the surgical scientist, and serves as both a critical review of existing literature and a reference guide for clinical research methodologies as they apply to surgery. The text addresses the clinical research questions facing 21st century surgeons, and provides clear direction on how to incorporate sophisticated research techniques into practice. In addition to the surgical generalist, this practical volume is specifically oriented to surgeons who treat unique diseases, yet have no single resource to facilitate clinical research in these specific areas.
This comprehensive and easy-to-use guide encompasses the entire process of clinical study design, application, and assessment. Part One is aimed at the young surgeon about to engage in new studies, and gives a general overview of the infrastructure of clinical research. Parts Two and Three are geared towards experienced investigators interested in pursuing clinical research and surgeons reviewing the literature for practical application. Part Two focuses on study design and related statistical issues, while Part Three is concerned with measuring and assessing the outcome of clinical studies. Part Four presents topics of interest to the active investigator, such as quality of care and cost-effectiveness analyses. Clinical Research Methods for Surgeons is relevant to both beginning investigators and established researchers, and addresses the unique concerns of surgical diseases and acknowledges that they require special approaches to deal with clinical questions.