Clinical Research Methods for Surgeons
David F. Penson
Springer Science & Business Media, Nov 6, 2007 - Medical - 350 pages
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.
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administrative analysis appropriate assessment associated bias budget calculated cardiac surgery censored centers clinical research clinical trials codes colorectal cancer comorbidities compared coronary costs Cox model criteria data collection databases defined determine developed disease effect end points evaluation event example hazard ratio HIPAA hospital HRQOL identify important individuals institution Institutional Review Board International intervention investigator JAMA measure Medicare meta-analysis methods morbidity mortality rates National Surgical Quality NSQIP number of deaths observational studies operations outcome of interest patient satisfaction patient-reported outcomes performed physicians population postoperative potential prevalence procedures prostate cancer prostate-specific antigen Quality Improvement Program radical prostatectomy randomized trial registries regression relevant reported research question risk factors risk-adjusted ROC curve sample screening sildenafil specific standard statistical subjects Surg surgeons surgery Surgical Quality Improvement Survey systematic reviews Table therapy treatment urinary incontinence validity variables Veterans Affairs