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.

Praise for this book:Readable, relevant, and interesting...this book cuts through jargon, recapitulates key concepts, and clarifies with current examples from the literature...recommend[ed].--Doody's ReviewClinical Research for Surgeons is a practical guide for understanding, planning, conducting, and evaluating surgical research. It covers the principles of evidence-based surgery and applies these principles to the design of suitable research studies. The reader will come to fully understand important concepts such as case-control study, prospective cohort study, randomized trial, and reliability study. The book provides valuable discussions of the critical appraisal of published clinical studies, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care.Highlights: Insights from experienced surgeons and veteran researchers Easy-to-reference text boxes with Key Concepts, Jargon Simplified, and Examples from the Literature Coverage of both open and minimally-invasive surgical procedures 50 illustrations demonstrating key points This book is a valuable reference for clinicians and residents in a range of disciplines, including general surgery, orthopedic surgery, plastic and reconstructive surgery, urology, neurosurgery, otolaryngology-head and neck surgery, interventional radiology, cardiac surgery.

This issue of Surgical Oncology Clinics of North America, guest edited by Dr. Elin R. Sigurdson, is devoted to Clinical Trials in Surgical Oncology. Dr. Sigurdson has assembled expert authors to review the following topics: Commentary on Randomized Controlled Trials; Randomized Clinical Trials in Soft Tissue Sarcoma; Randomized Clinical Trials in Gastrointestinal Stromal Tumors; Randomized Clinical Trials in Melanoma; Randomized Clinical Trials in Breast Cancer; Randomized Clinical Trials in Gastroesophageal Carcinoma; Randomized Clinical Trials in Hepatocellular Carcinoma; An Update on Randomized Clinical Trials in Advanced and Metastatic Colorectal Carcinoma; Randomized Clinical Trials in Colon and Rectal Cancer; Randomized Clinical Trials in Anal Cancers; The Elderly in Randomized Clinical Trials; Hereditary Syndromes in Clinical Trials; Future Clinical Trials: Genetically Driven Trials; Randomized Clinical Trials in Neuroendocrine Tumors, and more!

Contributors. -- Foreword. -- Preface. -- Getting Started. -- Assessing Available Information. -- Organizing and Preliminary Planning for Surgical Research -- Writing a Protocol: Animals, Humans, and Use of Biologic, Chemical, and Radiologic Agents. -- Grantsmanship. -- Informed Consent and the Protection of Human Research Subjects: Historical Perspectives and Guide to Current United States Regulations. -- Animal Care and Maintenance. -- Funding Strategies and Agencies: Academic-Industrial Relationships; Intellectual Property. -- Statistical Considerations. -- Use of Nonexperimental Studies to Evaluate Surgical Procedures and Other Interventions: The Challenge of Risk Adjustment. -- Measuring Surgical Outcomes. -- Design of Clinical Trials. -- Using Administrative Data for Clinical Research. -- Research in the Intensive Care Unit: Ethical and Methodological Issues. -- Research in the Operating Room. -- Effects of Age and Gender. -- Strategies, Principles, and Techniques Using Transgeni ...

Clinical Research for Surgeons is a practical guide for understanding, planning, conducting, and evaluating surgical research. It covers the principles of evidence-based surgery and applies these principles to the design of suitable research studies. The reader will come to fully understand important concepts such as case-control study, prospective cohort study, randomized trial, and reliability study. The book provides valuable discussions of the critical appraisal of published clinical studies, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care. Highlights: Insights from experienced surgeons and veteran researchers Easy-to-reference text boxes with Key Concepts, Jargon Simplified, and Examples from the Literature Coverage of both open and minimally-invasive surgical procedures 50 illustrations demonstrating key points This book is a valuable reference for clinicians and residents in a range of disciplines, including general surgery, orthopedic surgery, plastic and reconstructive surgery, urology, neurosurgery, otolaryngology-head and neck surgery, interventional radiology, cardiac surgery.

The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists

emerging on the surgical scene to challenge or For some readers, the title of this book will im thodoxy. Although these innovations are often mediately raise the question, what exactly is greeted with great optimism, a factual basis for meant by surgical research? In the very broadest that enthusiasm is sometimes far from secure sense the term can be taken to include all en and much further work is frequently required to deavors, however elementary or limited in discover whether we are dealing with genuine scope, to advance surgical knowledge. Ideally, advances or not. it refers to well-organized attempts to establish The most exciting and attractive scenario for on a proper scientific basis, i. e. , to place beyond surgical research is unquestionably one that de reasonable doubt, the truth or otherwise of any picts a successful attempt by a researcher to es concepts, old or new, within the ambit of sur gery, and, of course, anaesthesia. tablish the accuracy of some bold innovation for which he himself is responsible. Joseph Lister, The methods used to achieve that end vary demonstrating by clinical trial that wound sup enormously, depending on the issue being in vestigated.