Clinical Research Methods for Surgeons
Samenvatting
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.
Specificaties
Inhoudsopgave
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