TRANSLATIONAL SURGERY

1. Introduction
2. Translational Process
3. Scientific Method
4. Basic Research

Pre-Clinical
5. Overview of Preclinical Research
6. What Problem Are You Solving?
7. Types of Interventions
8. Drug Discovery
9. Drug Testing
10. Device Discovery and Prototyping
11. Medical Device Testing
12. Diagnostic Discovery
13. Diagnostic Testing
14. Other Product Types
15. Procedural Technique Development
16. Behavioral Intervention

Clinical: Fundamentals
17. Introduction to Clinical Research: What is it? Why is it needed?
18. The Question: Types of Research Questions and How to Develop Them
19. Study Population: Who and why them?
20. Outcome Measurements: What data is being collected and why?
21. Optimizing the question: Balancing significance and feasibility Statistical Principles
22. Basic Statistical Principles
23. Distributions
24. Hypotheses and Error Types
25. Power
26. Regression
27. Continuous Variable Analyses: T-test, Man Whitney, Wilcoxon Rank
28. Categorical Variable Analyses: Chi-Square, fisher exact, Mantel Hanzel
29. Analysis of Variance
30. Correlation
31. Biases
32. Basic Science Statistics

Clinical: Study Types
33. Design Principles: Hierarchy of Study Types
34. Case Series: Design, Measures, Classic Example
35. Case-Control: Design, Measures, Classic Example
36. Cohort Study: Design, Measures, Classic Example
37. Cross-Section Study: Design, Measures, Classic Example
38. Longitudinal Study: Design, Measures, Classic Example
39. Clinical Trials: Design, Measures, Classic Example
40. Meta-Analysis: Design, Measures, Classic Example
41. Cost-Effectiveness Study: Design, Measures, Classic Example
42. Diagnostic Test Evaluation: Design, Measures, Classic Example
43. Reliability Study: Design, Measures, Classic Example
44. Database Studies: Design, Measures, Classic Example
45. Surveys and Questionnaires: Design, Measures, Classic Example
46. Qualitative Methods and Mixed Methods

Clinical Trials
47. Randomized Control: Design, Measures, Classic Example
48. Nonrandomized Control: Design, Measures, Classic Example
49. Historical Control: Design, Measures, Classic Example
50. Cross-Over: Design, Measures, Classic Example
51. Withdrawal Studies: Design, Measures, Classic Example
52. Factorial Design: Design, Measures, Classic Example
53. Group Allocation: Design, Measures, Classic Example
54. Hybrid Design: Design, Measures, Classic Example
55. Large, Pragmatic: Design, Measures, Classic Example
56. Equivalence and Noninferiority: Design, Measures, Classic Example
57. Adaptive: Design, Measures, Classic Example
58. Randomization: Fixed or Adaptive Procedures
59. Blinding: Who and How?
60. Multicenter Considerations
61. Registries
62. Phases of Clinical Trials
63. IDEAL Framework
64. Artificial Intelligence
65. Patient Perspectives

Clinical: Preparation
66. Sample Size
67. Budgeting
68. Medical Ethics and Review Boards
69. Regulatory Considerations for New Drugs and Devices
70. Funding Approaches
71. Subject Recruitment
72. Data Management
73. Quality Control
74. Statistical Software
75. Report Forms: Harm and Quality of Life
76. Subject Adherence
77. Survival Analysis
78. Monitoring Committee in Clinical Trials

Regulatory Basics
79. FDA Overview
80. IND
81. New Drug Application
82. Devices
83. Radiation-emitting Electronic Products
84. Orphan Drugs
85. Biologics
86. Combination Products
87. Foods
88. Cosmetics
89. Non-US Regulatory

Clinical Implementation
90. Implementation Research
91. Design and Analysis
92. Population and Setting Specific Implementation

Public Health
93. Public Health
94. Epidemiology
95. Factors in Surgical Public Health and Health Disparities Research
96. Good Questions
97. Population and Environmental Specific Considerations
98. Law, Policy, and Ethics
99. Healthcare Institutions and Systems
100. Public Health Institutions and Systems

Practical Resources
101. Presenting Data
102. Manuscript Preparation
103. Building a Team
104. Patent Basics
105. Venture Pathways
106. SBIR/STTR
107. Sample Forms and Templates

• Focuses on translational general surgery and research, covering the principles of evidence-based medicine and applying these principles to the design of translational investigations
• Provides a practical, straightforward approach that will help aspiring general surgeons and researchers navigate challenging considerations in study design and implementation
• Details valuable discussions on the critical appraisal of published studies in general surgery, 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

Authors
• Adam E.M. Eltorai, Brown University Warren Alpert Medical School, Connecticut, USA.
• Jeffrey A. Bakal, Program Director, Provincial Research Data Services, Data Integration Management and Reporting of Alberta Health Services, Edmonton, Alberta, Canada.
• Paige C. Newell, Brigham and Women’s Hospital, Boston, MA, USA.
• Adena J. Osband, Department of Surgery, Warren Alpert Medical School of Brown University, Providence, RI, USA