Surgical Research

Surgical Research

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Product Details

ISBN-13: 9780080542140
Publisher: Elsevier Science
Publication date: 02/23/2001
Sold by: Barnes & Noble
Format: NOOK Book
Pages: 1460
File size: 44 MB
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From Chapter 12: Design of Clinical Trials

Therapies are commonly accepted into clinical practice on the basis of well-designed and well-conducted clinical trials. For example, the acceptance of lumpectomy and radiation therapy as an alternative treatment to mastectomy was based on results of prospective randomized trials (1-3). Although results of clinical trials often provide the underpinnings to general acceptance of specific treatments, the conclusions that can be drawn from trial results are often limited because of poor trial design. This chapter highlights basic principles surrounding the development and design of clinical trials.

Statistical associations can be made during retrospective analyses of data sets. In contrast, a clinical trial is usually required to determine whether these statistical associations are causal. Strictly speaking, retrospective analysis of data sets (such as chart review studies) can at best help develop hypotheses, which should then be tested by an experimental trial. Similarly, the design of clinical trials should be based on information available in retrospective analyses.

One of the most important elements of a clinical trial is the written protocol. The elements of a written protocol are described in Table I. All aspects of a clinical trial flow from this document, including the length of time required to complete the trial, the manpower required to collect necessary data during conduct of the trial, and the power of the statistical observations. Accordingly, as the protocol is developed, this critical document should be carefully written, revised, and edited with the same care and attention to detail as a National Institutes of Health grant application. The style and form of a written protocol should satisfy many of the same requirements as in a grant application. All who read the protocol will not be experts in the specific area of study. The protocol should therefore be written clearly and concisely. The study endpoints must allow one to address the specific aims directly. Patient eligibility must be broad enough to allow extrapolation of the trial results to the intended patient population, but must be narrow enough to permit meaningful analysis of the data. The clinical and laboratory data recorded during the conduct of the study must be sufficient to measure the stated endpoints. Collection of unnecessary data raises the cost of a trial and increases the likelihood that important information will not be captured and recorded.

Table of Contents

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 Transgenic and Knockout Mouse Models.
Tissue Culture, Cell Growth, and Analysis.
Hematopoietic Stem Cells: Basic Concepts and Applications to Surgical Research.
Base Molecular Biological Methods in Surgical Research: Genetic Library Construction, Screening, and DNA Sequencing.
Transcription.
Signal Transduction and Apoptosis.
Mechanisms and Regulation of Eukaryotic Protein Synthesis.
Organelle Studies: Mitochondria, Golgi, and Endoplasmic Reticulum.
Membrane Biology and Biophysics.
Molecular Epidemiology: Beyond Gene Discovery to Clinical Diagnostic Tools.
Shock Models: Hemorrhage.
Scoring Systems for Trauma Research.
Blunt Trauma Models: Fractures, Chest Trauma, Head Injury, Soft-Tissue Trauma, and Abdominal Trauma.
Trauma Models for Studying the Influence of Gender and Aging.
Animal Models of Burn Injury.
Wound Care Models.
Models of Adult Respiratory Distress Syndrome-Aspiration.
Tumor Angiogenesis.
Approaches to Adoptive Immunotherapy.
Metastasis: Biology and Experimental Models.
Cancer Genetics.
Cancer Gene Therapy.
Active Immunotherapy for Cancer.
Gastrointestinal Motility.
Models of Intestinal Secretion and Absorption.
Surgical Models of Inflammatory Bowel Disease.
Intestinal Regeneration and Adaptation Models.
Minimally Invasive Surgery.
Experimental Models and Endpoints for Studies of Intestinal Ischemia-Resperfusion Injury.
Gut Barrier Failure.
Developmental Studies in the Gastrointestinal Tract.
Animal Models of Liver Failure.
Portal Hypertension and Portacaval Shunt.
Animal Models of Liver Regeneration.
Animal Models for the Study of Hepatocyte Transplantation.
Biliary Stone Formation.
Models for the Study of Pancreatitis.
Models of Endocrine Insufficiency.
Animal Models in Transplantation.
Models to Study Surgical Nutrition and Metabolism.
Stable Isotopes.
Body Composition.
Energetics.
Models of Protein Metabolism.
Membrane Transport of Nutrients.
Models of Wound Healing in Growth Factor Studies.
Animal Models of Sepsis and the Multiple Organ Dysfunction Syndrome.
The Immuno-Inflammatory Response.
Antibiotic Trials.
Scoring Systems for Sepsis and the Multiple Organ Dysfunction Syndrome.
Cytokine Biology.
Biology of Nitric Oxide: Measurement, Modulation, and Models.
Endothelial Cell and Smooth Muscle Cell Biology in Vascular Disease.
Coagulation Biology.
Endovascular Research: Stents.
Noninvasive Vascular Measurements.
Techniques to Study Microcirculation.
Blood Substitutes in Surgery.
Research Models in Pediatric Surgery.
Research in Fetal Surgery.
Research in Plastic Surgery.
Research Methods in Neurosurgery.
Research in Urologic Surgery.
Research in Cardiac Surgery.
Research in Orthopedic Surgery.
Statistical Analysis-Specific Statistical Tests: Indications for Use.
Data Presentation: How to Write and Submit Abstracts and Papers.
Audiovisual Communications as a Research Skill.
Organizing and Managing Meetings and Conferences.
The Management and Organization of a Surgical Research Laboratory.
History and Philosophy of Surgical Research.
The Surgical Research Program as a Business Enterprise.
Nobel Laureates in Surgery.
Surgical Education Research.
Mathematical Modeling.
Information Resource Discovery for Surgeons: Databases and the Internet.
How to Review a Manuscript.
Academic Surgical Mentoring.
Ethics and Surgical Research.
The National Institutes of Health: Procedures and Performance.
Measuring the Performance of Surgical Research.
Virtual Reality and Surgery.
Surgeons and Health Services Research.
From Idea to Product: Financing and Regulatory Issues in Product Development.

What People are Saying About This

P.R. O'Connell

The editors have brought together nearly 200 authors, whose bibliography represents a 'who's who' of North American academic surgery. With this large faculty the editors have crafted 100 chapters, yet they have brought a uniformity of style and presentation that makes for easy reading. ...This is an important text. It is simply a must for every academic surgical department and a useful aid for every surgical trainee embarking on a research project. The time taken to read it is well spent and will be rewarded with time saved exploring blind alleys. (P.R. O'Connell, Mater Private Hospital, in British Journal of Surgery, February 2002)

Preface

From the Preface

The field of surgery is slowly undergoing a quiet revolution. Utilizing newer methods of pain control, understanding and reducing the perioperative stress response, and adapting minimally invasive operative techniques to many procedures have greatly improved patient outcomes with fewer complications, shorter hospital stays, and reduced convalescent recovery. Academic surgery is also undergoing profound changes, brought about by the financial shortfall constantly facing hospitals and the decreased reimbursement provided for professional services. Surgeons have responded to these pressures by increasing the number of operations they perform, thus devoting more time to service (e.g., patient care) and less time to the academic pursuit of research.

For many reasons, surgeons are decidedly qualified to carry out research. As a general rule, they have an extraordinary capacity for hard work and tend to be problem-focused and solution-oriented. Their technical skills provide them with the opportunity to access blood and tissues as well as to master complex bench techniques. Surgical patients are among the most challenging to care for, posing an almost endless number of hypotheses that can be tested through basic, clinical, and translational research. In spite of pressures to spend more time in the operating room, we believe that advances in the understanding of the pathophysiology and treatment of diseases will be improved if the surgical-scientist is a front line investigator.

Several years ago it became apparent that surgical science was being reemphasized, and several of us sought remedies to decelerate and reverse these changes. Acommittee of the American Surgical Association was formed to make recommendations, a biannual teaching conference (Young Surgical Investigators) and a Clinical Trials Methods Course were organized by the American College of Surgeons, and the annual program on Fundamentals of Surgical Research was initiated by the Association for Academic Surgery. In addition, the senior editors of this book reviewed the general field of surgical research and suggested approaches to evaluating output and to improving and quantitating productivity by applying research methodologies developed and utilized in industry.

Finally, we concluded that a reference source on surgical research would provide the foundation for this academic endeavor and would serve to prevent erosion of this important intellectual basis of our specialty. Not only would such a volume be a place for young investigators to start when initiating their research projects, but it would reflect the philosophy, history, evolution, and ethical basis of this broad field.

Initially, we were hesitant to propose such a project, but we were greatly encouraged by members of the editorial staff of Academic Press; our thanks go to Jasna Markovac and Graham Lees for their help in initiating and completing this project. We contacted five recognized research leaders who would subsequently serve as co-editors, and they enthusiastically supported the concept of codifying the basics of surgical research. We then wrote to over 100 surgical scientists, recognized experts in diverse fields, and asked them if they would be willing to contribute to this effort; the response was a unanimous yes!

This work is organized so that the material required for designing and starting a research project is found at the front of the book, the methods and techniques required to perform the investigation are found in the middle of the volume, and the skills needed for analyzing, writing, and presenting the material follow. Overviews of research efforts in surgical subspecialties are also included, followed by chapters on the history of surgical research, the integration of research into a clinical department, biographies of surgeons who have been awarded the Nobel Prize, and a précis on converting an idea to a product.

The scope of the text is quite broad, and we have made every effort for the reader to use this information as a spring- board to find new ideas and information by way of the Inter-net and traditional medical libraries. The text is also supported by a Web site (http:\\www.academicpress.com/surgery), which will continue to provide updated information on new methodology and techniques in a variety of fields. We hope that this method of communication will keep our readers updated and current and will enhance the exchange of information within the surgical community.

Surgeons are in the best position to improve surgical care. By evaluating our outcomes and addressing our clinical problems, surgeons can use scientific methodology to enhance recovery of the surgical patient. We hope that Surgical Research will serve in some small way to support this effort.

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