Full Description
Translational Sports Medicine covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. This title is an indispensable tool in grant writing and funding efforts with its practical, straightforward approach that will help aspiring investigators navigate challenging considerations in study design and implementation. It provides valuable discussions of the critical appraisal of published studies in translational sports medicine, 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.
In short, this practical guidebook will be of interest to every medical researcher or sports medicine clinician who has ever had a good clinical idea but not the knowledge of how to test it. Readers will come to fully understand important concepts, including case-control study, prospective cohort study, randomized trial and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in translational sports medicine, and know what is needed in collaboration.
Contents
INTRODUCTION
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. Beyond Drugs and Surgery: A Look at Orthobiologics
9. Drug Testing
10. Device Discovery and Prototyping
11. Device Testing
12. Diagnostic Discovery
13. Diagnostic Testing
14. Preclinical: discussion of FDA product categories (what the FDA covers, regulated or not)
15. Procedural Technique Development
16. Behavioral Intervention studies
17. Artificial Intelligence
CLINICAL: FUNDAMENTALS
18. Introduction to Clinical Research: What is it? Why is it Needed?
19. The Question: Types of Research question and How to Develop Them
20. Study Population: Who and Why Them?
21. Outcome Measurements: What data is being Collected and Why?
22. Optimizing the Question: Balancing Significance and Feasibility
STATISTICAL PRINCIPLES
23. Common Issues in Analysis
24. Basic Statistical Principles
25. Distribution
26. Research hypotheses and Error Types
27. Power
28. Multivariable regression models
29. How to choose appropriate bivariate test
30. Categorical Variable Analyses: Chi-square, Fisher exact, Mantel-Haenszel
31. Analysis of Variance: ANOVA
32. Correlation
33. Statistical bias
34. Basic Science Statistics
35. Sample Size
36. Statistical Software
CLINICAL: STUDY TYPES
37. Design Principles: Hierarchy of Study Types
38. Case Series: Design, Measures, and an Example
39. Case-control Study
40. Cohort Studies
41. Cross-section Study
42. Longitudinal Study: Design, Measures, Classic Example
43. Meta-analysis
44. Cost-effectiveness Study: Design, Measures, Classic Example
45. Diagnostic Test Evaluation: Design, Measures, Classic Example
46. Reliability Study: Design, Measures, Classic Example
47. Database Types and Basic Data Management Design Principles for Healthcare Research
48. Survey Studies and Questionnaires
49. Qualitative Methods and Mixed Methods
CLINICAL: TRIALS
50. Randomized and Controlled Trials
51. Nonrandomized Controlled Trials
52. Historical Control: Design, Measures, Classic Example
53. Cross-over Studies
54. Withdrawal Studies: Design, Measures, Classic Example
55. Factorial Design: Design, Measures, Classic Example
56. Group or Cluster Controlled Trials: Design, Measures, Classic Example
57. Hybrid Design: Design, Measures, Classic Example
58. Large, Pragmatic: Clinical Trials
59. Equivalence and Noninferiority: Design, Measures, Classic Example
60. Adaptive Design Measures
61. Randomization: Fixed or Adaptive Procedures
62. Blinding: Who, When, and and How?
63. Multicenter Consideration
64. Phase 0 Trials: Window of Opportunity
65. Registries
66. Phases of Clinical Trials
67. IDEAL Framework
CLINICAL PREPARATION
68. Patient Perspectives
69. Budgeting
70. Ethics and Review Boards
71. Regulatory Considerations for Sports Medicine Technologies: New Drugs and Medical Devices
72. Funding Approaches
73. Conflicts of Interest
74. Subject Recruitment
75. Data Management
76. A Practical Guide to Conducting Research in the Acute Setting
77. Special Populatoins
78. Subject Adherence
79. Time-to-Event Outcomes and Survival Analysis
80. Monitoring Committee in Clinical Trials
REGULATORY BASICS
81. FDA Overview
82. Investigational New Drug (IND) Application
83. New Drug Application
84. Medical Devices
85. Radiation-emitting Electronic Products
86. Orphan Drugs
87. Biological Drugs
88. Combination Products
89. Cosmetics in Sports Medicine
90. CMC and GxP
91. Non-US Regulatory
92. Post-Market Drug Safety Monitoring
93. Post-Market Device Safety Monitoring
CLINICAL IMPLEMENTATION
94. Implementation Research
95. Design and Analysis
96. Mixed-methods Research
97. Implementation of Multimodal Concussion Research Within Military Medical Environments
98. Guideline Development
PUBLIC HEALTH
99. Public Health
100. Edpidemiology of Sports Injuries
101. Factors
102. Good Questions
103. Population and Environmental Specific Considerations
104. Law, Policy, and Ethics
105. Healthcare Institutions and Systems
106. Public Health Institutions and Systems
PRACTICAL RESOURCES
107. Presenting Data
108. Manuscript Preparation
109. Promoting Research
110. Quality Improvement
111. Team Science and Building a Team
112. Types of Intellectual Property
113. Venture Pathways
114. Utilizing National Institutes of Health (NIH) Grants to Fund Translational Research
115. Sample Forms and Templates
