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.

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.

Part I. Building a Foundation for Clinical Research Planning the Research Eugene H. Blackstone Ethical Issues in Clinical Research David F. Penson Budget Development and Staffing Judith Fine and Peter C. Albertsen Part II. Clinical Research Design and Statistical Techniques Nonrandomized Interventional Study Designs (Quasi-Experimental Designs) David A. Axelrod and Rodney Hayward Randomized Clinical Trials of Surgical Procedures Michael P. Porter Use of Observational Databases (Registries) in Research Deborah P. Lubeck Risk Adjustment William G. Henderson and Shukri F. Khuri Basic Statistical Methods David Etzioni, Nadia Howlader, and Ruth Etzioni Survival Analyses Rodney L. Dunn and John T. Wei Assessing the Performance and Validity of Diagnostic Tests and Screening Programs David C. Miller, Rodney L. Dunn, and John T. Wei Secondary Data Analyses Andrew L. Rosenberg, MaryLou V. H. Greenfield, and Justin B. Dimick Part III. Outcome Measurement Traditional Outcome Measures Aruna V. Sarma and Julie C. McLaughlin Health-Related Quality of Life Mark S. Litwin Measuring Patient Satisfaction Arvin Koruthu George and Martin G. Sanda Part IV. Special Topics in Surgical Clinical Research Quality of Care Jessica B. O'Connell and Clifford Y. Ko Cost-Effectiveness Analyses Lynn Stothers Qualitative Research Techniques Donna L. Berry, Sally L. Maliski, and William J. Ellis Systematic Reviews and Meta-Analyses Timothy J. Wilt and Howard A. Fink Index

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.