Clinical Research Methods for Surgeons / Edition 1

by David F. Penson

Overview

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.

Product Details

ISBN-13:	9781617374968
Publisher:	Springer-Verlag New York, LLC
Publication date:	11/05/2010
Edition description:	Softcover reprint of hardcover 1st ed. 2007
Pages:	350
Product dimensions:	7.01(w) x 10.00(h) x 0.03(d)

Table of Contents

Building a Foundation for Clinical Research.- Planning the Research.- Ethical Issues in Clinical Research.- Budget Development and Staffing.- Clinical Research Design and Statistical Techniques.- Nonrandomized Interventional Study Designs (Quasi-Experimental Designs).- Randomized Clinical Trials of Surgical Procedures.- Use of Observational Databases (Registries) in Research.- Risk Adjustment.- Basic Statistical Methods.- Survival Analyses.- Assessing the Performance and Validity of Diagnostic Tests and Screening Programs.- Secondary Data Analyses.- Outcome Measurement.- Traditional Outcome Measures.- Health-Related Quality of Life.- Measuring Patient Satisfaction.- Special Topics In Surgical Clinical Research.- Quality of Care.- Cost-Effectiveness Analyses.- Qualitative Research Techniques.- Systematic Reviews and Meta-Analyses.

Editorial Reviews

Reviewer: David James Dries, MSE, MD (Regions Hospital)
Description: This guide describes the evolution of clinical research standards and development of clinical research projects using surgical models.
Purpose: Clinical study design applications and assessment are emphasized and methods for reviewing scientific literature are presented.
Audience: Senior trainees, reviewers, and workers with scientific literature are an appropriate audience for this work. Authors include leaders of the clinical research groups of major North American universities and the Veterans Administration Hospital System.
Features: After a review of the history and principles of clinical research organization, the heart of this book reviews statistical techniques with references displaying various types of research design. Strengths and weakness of contemporary studies are discussed. Experimental methods include observational trials, risk adjustment, survival analysis, and secondary data analysis techniques. Concluding chapters discuss contemporary outcome measures including cost effectiveness, meta-analysis and quality of life. Chapters are written in an easy conversational style and make excellent use of tables and line drawings for display of raw data. Each chapter is referenced with primary and secondary sources. Where contemporary topics are discussed, references are appropriate in number and date to within one to two years of publication.
Assessment: Excellent details with effective examples are provided for the beginning or experienced investigator. The methods included here are essential to justify use of techniques and technologies with growing cost and complexity. In conjunction with a statistics package, this is an effective guide to clinical research.

Doody's Review Service

"There are larger reference texts but the simplicity of this book makes it an ideal place to start." -British Journal of Surgery

From the Publisher