Clinical Research Methods for SurgeonsDavid F. Penson 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. |
Contents
Budget Development and Staffing | 47 |
QuasiExperimental Designs | 63 |
OUTCOME MEASUREMENT | 64 |
Randomized Clinical Trials of Surgical Procedures | 77 |
Use of Observational Databases Registries in Research | 95 |
Risk Adjustment | 105 |
Basic Statistical Methods | 123 |
Survival Analyses | 141 |
Secondary Data Analyses | 175 |
Traditional Outcome Measures | 203 |
HealthRelated Quality of Life | 237 |
Measuring Patient Satisfaction | 253 |
SPECIAL TOPICS IN SURGICAL CLINICAL RESEARCH | 267 |
CostEffectiveness Analyses | 283 |
Qualitative Research Techniques | 297 |
Systematic Reviews and MetaAnalyses | 311 |
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adjustment administrative analysis approach appropriate assessment associated bias calculated cancer centers changes clinical clinical research clinical trials codes collection compared comparison considered costs criteria databases datasets death defined determine developed disease distribution Drug effect estimate evaluation event evidence example expected experience factors Figure function groups hospital identify important Improvement increase independent indicates individuals institution interest internal intervention limited means measure methods morbidity mortality negative NSQIP observational occur operations outcomes participants patients performed period population positive postoperative potential practice predictive probability procedures Program prostate cancer question randomized receive REFERENCES registries regression reported represents response risk sample satisfaction screening selection sensitivity significant sources specific standard statistical status subjects Surg surgeon surgery surgical Table treatment trials United validity variables