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Translational Orthopedics

  • 1st Edition - April 15, 2024
  • Latest edition
  • Editors: Jeffrey A. Bakal, Jack M. Haglin, Joseph Abboud, Joseph J. Crisco, Adam E.M. Eltorai
  • Language: English

Translational Orthopedics: Designing and Conducting Translational Research covers the principles of evidence-based medicine and applies these principles to the design of translati… Read more

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Description

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.

Key features

  • Focuses on the principles of evidence-based medicine and applies these principles to the design of translational investigations within orthopedics
  • Provides a practical, straightforward approach that helps investigators navigate challenging considerations in study design and implementation
  • Details discussions of the critical appraisal of published studies in translational orthopedics, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care

Readership

Researchers interested in translating their research into clinical practice

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

Product details

  • Edition: 1
  • Latest edition
  • Published: April 18, 2024
  • Language: English

About the editors

JB

Jeffrey A. Bakal

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

JA

Joseph Abboud

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.

Affiliations and expertise
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

JC

Joseph J. Crisco

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.
Affiliations and expertise
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

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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