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Elsevier

Translational Sports Medicine

  • 1st Edition - August 14, 2023
  • Latest edition
  • Editors: Jeffrey A. Bakal, Steve DeFroda, Brett D. Owens, Adam E.M. Eltorai
  • Language: English

Translational Sports Medicine covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. This title is an indisp… Read more

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.

Key features

  • Focuses on the principles of evidence-based medicine and applies these principles to translational investigations within sports medicine
  • Details discussions of the critical appraisal of published studies in translational sports medicine, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care
  • Written by experts in the sports medicine field

Readership

Clinicians in sports medicine, basic scientists interested in translating their research into clinical practice, Graduate level programs in clinical investigation

Table of 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

Review quotes

"This book is a comprehensive how-to for sports medicine researchers at all levels...includes practical guidelines, such as figures on FDA premarketing processes for medical device classification, thus serving as a reference to better understand regulatory entities...[A] guide for health care providers and scientists to improve the quality of the literature coming out of the sports medicine field [and] a step-by-step detailed manuscript that starts by outlining how to write a research question and what pitfalls to avoid when doing so...This book is unique because it focuses on sports and musculoskeletal medicine, discussing relevant sports technologies, medical devices, and interventions such as biologics injections, and addresses potential issues that are unique to sports medicine research...The book is organized chronologically, in a way that is easy for the reader to follow as they actively go through the process of conducting translational research."—©Doody’s Review Service, 2024, Yuka Kobayashi, DO (Medical College of Wisconsin)

Product details

  • Edition: 1
  • Latest edition
  • Published: August 14, 2023
  • Language: English

About the editors

JB

Jeffrey A. Bakal

Dr 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.
Affiliations and expertise
Division General Internal Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton Alberta, Canada

SD

Steve DeFroda

Steven DeFroda currently works as a sports medicine fellow at Rush University Medical Center. Steven does research in Orthopedic Surgery, with specific interest in athletic injuries of the knee, shoulder, and elbow. Specific interests include clinical and functional outcomes, biomechanics, and patient quality of life.
Affiliations and expertise
Sports Medicine Fellow, Rush University Medical Center, Columbia, MO, USA

BO

Brett D. Owens

Dr. Owens is a fellowship-trained, board certified orthopedic sports medicine surgeon, specializing in arthroscopic repair of sports-related injuries as well as complex knee and shoulder reconstructions. He is Chief of Sports Medicine at the Miriam Hospital in Providence, RI and Director of the Rhode Island Cartilage Repair Center. He is Professor of Orthopaedic Surgery at Brown University Alpert Medical School. He is currently a Team Physician for Brown University and the Providence Bruins. He serves as a consultant for URI Athletics. Dr. Owens was named by fellow orthopedists in Orthopedics This Week as one of the “Top 28 North American Knee Surgeons.” He has published over 200 articles in peer-reviewed medical journals, given over 200 national or international presentations, co-edited three textbooks on orthopedic injuries, and serves as Associate Editor for the American Journal of Sports Medicine. His research has garnered awards from the American Orthopedic Society for Sports Medicine.
Affiliations and expertise
Chief of Sports Medicine at the Miriam Hospital in Providence, RI; Director of the Rhode Island Cartilage Repair Center; Professor of Orthopaedic Surgery at Brown University Alpert Medical School; Team Physician for Brown University and the Providence Bruins

AE

Adam E.M. Eltorai

Dr 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.

Affiliations and expertise
Harvard Medical School, Boston, MA, USA

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