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