Translational Orthopedics: Designing and Conducting Translational Research covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. 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 orthopedics, and know what is needed in collaboration. Further, this title is an indispensable tool in grant writing and funding efforts.
The practical, straightforward approach helps the aspiring investigator navigate challenging considerations in study design and implementation. The book provides valuable discussions of the critical appraisal of published studies in translational orthopedics, 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 Orthopedist who has ever had a good clinical idea but not the knowledge of how to test it.
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Table of Contents
Preface
Adam E. M. Eltorai
Introduction
1. Introduction
2. Translational Process
3. Scientific Method
4. Basic research
PRE-CLINCIAL
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. 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
18. The question
19. Study population
20. Outcome measurements
21. Optimizing the question
STATISTICAL PRINCIPLES
22. Common issues in analysis
23. Basic statistical principles
24. Distributions
25. Hypotheses and error types
26. Power
27. Regression
28. Continuous variable analyses
29. Categorical variable analyses
30. Analysis of variance
31. Correlation
32. Biases
33. Basic science statistics
CLINICAL: STUDY TYPES
34. Design principles
35. Case series
36. Case-control study
37. Cohort study
38. Cross-section study
39. Longitudinal Study
40. Clinical trials
41. Meta-analysis
42. Cost effectiveness study
43. Diagnostic test evaluation
44. Reliability study
45. Database studies
46. Surveys and questionnaires
47. Qualitative methods and mixed methods
CLINICAL TRIALS
48. Randomized control
49. Nonrandomized control
50. Historical control
51. Cross-over
52. Withdrawal studies
53. Factorial design
54. Group allocation
55. Hybrid design
56. Large, pragmatic
57. Adaptive
58. Randomization
59. Blinding
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. Ethics and review boards
69. Regulatory considerations for new drugs and devices
70. Funding approaches
71. Subject recruitment
72. Data management
74. Statistical Software
75. Report forms
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 Productions
87. Foods
88. Cosmetics
89. CMC and GxP
90. Non-US regulatory
91. Post-market drug safety monitoring
92. Post-market device safety monitoring
CLINICAL IMPLEMENTATION
93. Implementation Research
94. Design and Analysis
95. Mixed Methods Research
96. Population- and setting-specific implementation
PUBLIC HEALTH
97. Public Health
98. Epidemiology
99. Factors
100. Good questions
101. Population- and environmental-specific considerations
102. Law, policy, and ethics
103. Healthcare institutions and systems
104. Public health institutions and systems
Practical Resources
105. Presenting data
106. Manuscript preparation
107. Building a team
108. Patent basics
109. Venture pathways
110. SBIR/STTR
111. Sample forms and templates
Authors
Jeffrey A. Bakal Division General Internal Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton Alberta, Canada. Jeff Bakal PhD, P.Stat. is the Program Director for Provincial Research Data Services at Alberta Health Services which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform and Health Service Statistical & Analytics Methods teams. He has over 10 years of experience working with Health Services data and Randomized Clinical Trials. He completed his PhD jointly with the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen's University. He has worked on the methodology and analysis of several international studies in business strategy, ophthalmology, cardiology, geriatric medicine and the analysis of kinematic data resulting in several peer reviewed articles and conference presentations. His current interests are in developing statistical methodology for time-to-event data and the development of classification tools to assist in patient decision making processes. Jack M. Haglin Joseph Abboud Professor of Shoulder and Elbow Surgery Department of Orthopedics The Sidney Kimmel Medical College Thomas Jefferson University Chief Medical Officer Rothman Orthopedics Philadelphia, PA , USA.Dr. Abboud is a Board Certified Orthopaedic Surgeon and specializes in the treatment of patients with shoulder and elbow disorders. He is an internationally recognized authority on the treatment of shoulder and elbow disorders. He is a Professor of Orthopaedic Surgery at the Sidney Kimmel Medical College of Thomas Jefferson University and a core member of the teaching faculty for Rothman Orthopaedics. Dr. Abboud received his medical degree with honors from Georgetown University School of Medicine and went on to complete his residency in Orthopaedic surgery at the Hospital of the University of Pennsylvania where he served as the administrative chief resident and received the award. He subsequently completed two (one-year) fellowships at the University of Pennsylvania in Shoulder and Elbow surgery and Orthopaedic Biomechanics. Dr. Abboud has published over 250 peer reviewed publications, given over 600 invited lectures nationally and internationally, and published several textbooks and numerous book chapters. He has received the prestigious Neer award and Burkhardt award for excellence in research. Dr. Abboud performs a wide variety of simple and complex surgical procedures on the shoulder and elbow including arthroscopic surgery (e.g. rotator cuff repairs, instability surgery) comprehensive fracture care, as well as shoulder and elbow replacement (arthroplasty) procedures. Dr. Abboud is most proud of the fact that he has been caring for patients throughout the Philadelphia region and the Northeast region of the United States. Patients seek out his care from all regions of the United States and overseas. His goal is to always provide each patient with exceptional personalized care.
Joseph J. Crisco Henry Frederick Lippitt Professor of Orthopaedic Research; Executive Director for Research, Department of Orthopaedics; Director Bioengineering Laboratory, Department of Orthopaedics, The Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence, RI United States. Prof. J.J. Trey Crisco research interests are in musculoskeletal biomechanics where he focuses on upper extremity mechanics and osteoarthritis using advanced imaging analysis and on neuromuscular therapy. He also has an extensive interest in sports injury prevention and performance. His work has been primarily funded by the NIH and has resulted in over 200 peer-reviewed publications. He serves on several NIH study sections, editorial boards, and the scientific advisory committees of International Federation of Women's Lacrosse, US Lacrosse and USA Baseball. Prof. Crisco is a former Editor-in-Chief of the Journal of Applied Biomechanics and President of the American Society of Biomechanics. He has previously taught Basic Biomechanics and Product Design and Development, a joint effort between Industrial Design Department at RISD and Engineering at Brown University. He provides guest lectures and supports undergraduates for their independent studies and honors work, master's and doctoral students in his lab. Adam E.M. Eltorai Harvard Medical School, Boston, MA, USA.Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.
