Clinical Research for Surgeons

Clinical Research for Surgeons is a practical guide for understanding, planning, conducting, and evaluating surgical
research. It covers the principles of evidence-based surgery and applies these principles to the design of suitable
research studies. The reader will come to fully understand important concepts such as case-control study, prospective
cohort study, randomized trial, and reliability study. The book provides valuable discussions of the critical appraisal
of published clinical studies, allowing the reader to learn how to evaluate the quality of such studies with respect to
measuring outcomes and to make effective use of all types of evidence in patient care.

Highlights:

Insights from experienced surgeons and veteran researchers

Easy-to-reference text boxes with Key Concepts, Jargon Simplified, and Examples from the Literature

Coverage of both open and minimally-invasive surgical procedures

70 illustrations demonstrating key points

This book is a valuable reference for clinicians and residents in a range of disciplines, including general surgery,
orthopaedic surgery, plastic and reconstructive surgery, urology, neurosurgery, otolaryngology-head and neck surgery,
interventional radiology, cardiac surgery.

Table of Contents
Part I Why We Need Clinical Research
1 Historical Perspectives of Clinical Research . 3
2 Evidence-Based Surgery Defined . . . . . . . . . . 8
3 Myths and Misconceptions about Evidence-
Based Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4 Becoming an Evidence-Based Surgeon . . . . . 20
Part II Principles of Clinical Research
5 Various Research Design Classifications . . . . 31
6 Hierarchy of Research Studies: From Case
Series to Meta-Analyses . . . . . . . . . . . . . . . . . . 37
7 Randomized and Nonrandomized Studies . . 44
Part II A Understanding Research Study Design
8 The Clinical Case Series . . . . . . . . . . . . . . . . . . . 47
9 The Case.Control Study . . . . . . . . . . . . . . . . . . 49
10 The Prospective Cohort Study . . . . . . . . . . . . . 55
11 The Randomized Trial . . . . . . . . . . . . . . . . . . . . 59
12 Meta-Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
13 Economic Analysis . . . . . . . . . . . . . . . . . . . . . . . 77
14 The Diagnostic Study . . . . . . . . . . . . . . . . . . . . 85
15 The Reliability Study . . . . . . . . . . . . . . . . . . . . . 91
Part II B Understanding Outcomes Measurement
16 The Classification of Outcomes . . . . . . . . . . . 101
17 What Makes an Outcome Measure Useful . . 107
18 Common Generic Outcome Scales
for Surgeons . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
19 Common Disease-Specific Outcome
Scales for Surgeons . . . . . . . . . . . . . . . . . . . . . . 116
Part II C Understanding Treatment Effects
20 Common Ways to Present Treatment Effects 121
21 The Confidence Interval Defined . . . . . . . . . . 127
22 The P Value Defined . . . . . . . . . . . . . . . . . . . . . 132
23 Errors in Hypothesis Testing . . . . . . . . . . . . . . 135
24 Clinical versus Statistical Significance . . . . . . 139
Part III Practice of Clinical Research
Part III A Planning a Research Study
25 The Requirements of a Clinical Research
Proposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
26 The Identification of a Good Research
Question . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
27 How to Conduct a Comprehensive
Literature Search . . . . . . . . . . . . . . . . . . . . . . . . 158
28 Guide to Planning a Randomized Trial . . . . . . 164
29 Guide to Planning a Nonrandomized Study 170
30 Study Sample Size . . . . . . . . . . . . . . . . . . . . . . . 177
31 How to Budget for a Research Study . . . . . . . 181
32 Research Ethics, Review Boards,
and Consent Forms . . . . . . . . . . . . . . . . . . . . . . 196
33 Regulatory Issues in the Evaluation of a
New Device or Drug . . . . . . . . . . . . . . . . . . . . . 203
34 Strategies in Research Funding . . . . . . . . . . . . 210
Part III B Conducting a Research Study
35 The Roles of the Research Team . . . . . . . . . . 215
36 The Role of a Central Methods Center . . . . . 222
37 The Role of a Data Monitoring Committee. . 230
38 The Need for Separate Adjudication
of Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
39 Data Management . . . . . . . . . . . . . . . . . . . . . . . 243
40 Study Case Report Forms . . . . . . . . . . . . . . . . 248
41 The Study Manual of Operations . . . . . . . . . . 258
Part III C Practical Guide to Statistical Analysis
42 Review of Basic Statistical Principles . . . . . . . 269
43 Statistical Means and Proportions . . . . . . . . . 279
44 Regression Analysis . . . . . . . . . . . . . . . . . . . . . . 288
45 Analysis of Variance . . . . . . . . . . . . . . . . . . . . . 294
46 Correlation Defined . . . . . . . . . . . . . . . . . . . . . . 301
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 309
X Table of Contents