Part I Why We Need Clinical Research
1 Historical Perspective of Clinical Research
2 Evidence-Based Surgery Defined
3 Myths and Misconceptions about Evidence-Based Medicine
4 Becoming and Evidence-Based Surgeon
Part II Principles of Clinical Research
5 Various Research Design Classifications
6 Hierarchy of Research Studies: From Case Series to Meta-Analyses
7 Randomized and Nonrandomized Studies
Part IIA Understanding Research Study Design
8 The Clinical Case Series
9 The Case&ndsah;Control Study
10 The Prospective Cohort Study
11 The Randomized Trial
12 Meta-Analyses
13 Economic Analysis
14 The Diagnostic Study
15 The Reliability Study
Part IIB Understanding Outcomes Measurement
16 The Classification of Outcomes
17 What Makes an Outcome Measure Useful
18 Common Generic Outcome Scales for Surgeons
19 Common Disease-Specific Outcome Scales for Surgeons
Part IIC Understanding Treatment Effects
20 Common Ways to Present Treatment Effects
21 The Confidence Interval Defined
22 The P Value Defined
23 Errors in Hypothesis Testing
24 Clinical versus Statistical Significance
Part III Practice of Clinical Research
Part IIIA Planning a Research Study
25 The Requirements of a Clinical Research Proposal
26 The Identification of a Good Research Question
27 How to Conduct a Comprehensive Literature Search
28 Guide to Planning a Randomized Trial
29 Guide to Planning a Nonrandomized Study
30 Study Sample Size
31 How to Budget for a Research Study
32 Research Ethics, Review Boards, and Consent Forms
33 Regulatory Issues in the Evaluation of a New Device or Drug
34 Strategies in Research Funding
Part IIIB Conducting a Research Study
35 The Roles of the Research Team
36 The Role of a Central Methods Center
37 The Role of a Data Monitoring Committee
38 The Need for Separate Adjudication of Outcomes
39 Data Management
40 Study Case Report Forms
41 The Study Manual of Operations
Part IIIC Practical Guide to Statistical Analysis
42 Review of Basic Statistical Principles
43 Statistical Means and Proportions
44 Regression Analysis
45 Analysis of Variance
46 Correlation Defined