Clinical Research Methods for Surgeons

1. Front Matter

   Pages i-xiv

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2. Building a Foundation for Clinical Research

   1. Front Matter

      Pages 1-1

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   2. Planning the Research

      • Eugene H. Blackstone

      Pages 3-29

   3. Ethical Issues in Clinical Research

      • David F. Penson

      Pages 31-46

   4. Budget Development and Staffing

      • Judith Fine, Peter C. Albertsen

      Pages 47-60

3. Clinical Research Design and Statistical Techniques

   1. Front Matter

      Pages 61-61

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   2. Nonrandomized Interventional Study Designs (Quasi-Experimental Designs)

      • David A. Axelrod, Rodney Hayward

      Pages 63-76

   3. Randomized Clinical Trials of Surgical Procedures

      • Michael P. Porter

      Pages 77-93

   4. Use of Observational Databases (Registries) in Research

      • Deborah P. Lubeck

      Pages 95-104

   5. Risk Adjustment

      • William G. Henderson, Shukri F. Khuri

      Pages 105-122

   6. Basic Statistical Methods

      • David Etzioni, Nadia Howlader, Ruth Etzioni

      Pages 123-139

   7. Survival Analyses

      • Rodney L. Dunn, John T. Wei

      Pages 141-155

   8. Assessing the Performance and Validity of Diagnostic Tests and Screening Programs

      • David C. Miller, Rodney L. Dunn, John T. Wei

      Pages 157-174

   9. Secondary Data Analyses

      • Andrew L. Rosenberg, MaryLou V. H. Greenfield, Justin B. Dimick

      Pages 175-200

4. Outcome Measurement

   1. Front Matter

      Pages 201-201

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   2. Traditional Outcome Measures

      • Aruna V. Sarma, Julie C. McLaughlin

      Pages 203-235

   3. Health-Related Quality of Life

      • Mark S. Litwin

      Pages 237-251

   4. Measuring Patient Satisfaction

      • Arvin Koruthu George, Martin G. Sanda

      Pages 253-265

5. Special Topics In Surgical Clinical Research

   1. Front Matter

      Pages 267-267

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   2. Quality of Care

      • Jessica B. O’Connell, Clifford Y. Ko

      Pages 269-282

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.

• behavior
• clinical research
• complication
• diseases
• documentation
• epidemiology
• ethical issues
• health
• organizations
• patients
• planning
• quality
• quality of life
• statistics
• surgery

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

• Departments of Urology and Preventive Medicine Keck School of Medicine, University of Southern California, Los Angeles

  David F. Penson

• Department of Urology, University of Michigan Medical School, Ann Arbor

  John T. Wei

Policies and ethics