Adam E.M. Eltorai,
Adam Eltorai,
Jeffrey A. Bakal,
Jeffrey A Bakal,
Steve DeFroda,
Brett D. Owens
e.a.
Elsevier Science
e druk, 2023
9780323912594
Translational Sports Medicine
Specificaties
Paperback, blz.
|
Engels
Elsevier Science |
e druk, 2023
ISBN13: 9780323912594
Rubricering
Onderdeel van serie
Handbook for Designing and Conducting Clinical and Translational Research
Verwachte levertijd ongeveer 9 werkdagen
Samenvatting
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.
Specificaties
Inhoudsopgave
<p>INTRODUCTION<br>1. Introduction<br>2. Translational Process<br>3. Scientific Method<br>4. Basic Research</p><p>PRE-CLINICAL<br>5. Overview of preclinical research<br>6. What Problem Are You Solving?<br>7. Types of Interventions<br>8. Beyond Drugs and Surgery: A Look at Orthobiologics<br>9. Drug Testing<br>10. Device Discovery and Prototyping<br>11. Device Testing<br>12. Diagnostic Discovery<br>13. Diagnostic Testing<br>14. Preclinical: discussion of FDA product categories (what the FDA covers, regulated or not)<br>15. Procedural Technique Development<br>16. Behavioral Intervention studies<br>17. Artificial Intelligence</p><p>CLINICAL: FUNDAMENTALS<br>18. Introduction to Clinical Research: What is it? Why is it Needed?<br>19. The Question: Types of Research question and How to Develop Them<br>20. Study Population: Who and Why Them?<br>21. Outcome Measurements: What data is being Collected and Why?<br>22. Optimizing the Question: Balancing Significance and Feasibility</p><p>STATISTICAL PRINCIPLES<br>23. Common Issues in Analysis<br>24. Basic Statistical Principles<br>25. Distribution<br>26. Research hypotheses and Error Types<br>27. Power<br>28. Multivariable regression models<br>29. How to choose appropriate bivariate test<br>30. Categorical Variable Analyses: Chi-square, Fisher exact, Mantel-Haenszel<br>31. Analysis of Variance: ANOVA<br>32. Correlation<br>33. Statistical bias<br>34. Basic Science Statistics<br>35. Sample Size<br>36. Statistical Software</p><p>CLINICAL: STUDY TYPES<br>37. Design Principles: Hierarchy of Study Types<br>38. Case Series: Design, Measures, and an Example<br>39. Case-control Study<br>40. Cohort Studies<br>41. Cross-section Study<br>42. Longitudinal Study: Design, Measures, Classic Example<br>43. Meta-analysis<br>44. Cost-effectiveness Study: Design, Measures, Classic Example<br>45. Diagnostic Test Evaluation: Design, Measures, Classic Example<br>46. Reliability Study: Design, Measures, Classic Example<br>47. Database Types and Basic Data Management Design Principles for Healthcare Research<br>48. Survey Studies and Questionnaires<br>49. Qualitative Methods and Mixed Methods</p><p>CLINICAL: TRIALS<br>50. Randomized and Controlled Trials<br>51. Nonrandomized Controlled Trials<br>52. Historical Control: Design, Measures, Classic Example<br>53. Cross-over Studies<br>54. Withdrawal Studies: Design, Measures, Classic Example<br>55. Factorial Design: Design, Measures, Classic Example<br>56. Group or Cluster Controlled Trials: Design, Measures, Classic Example<br>57. Hybrid Design: Design, Measures, Classic Example<br>58. Large, Pragmatic: Clinical Trials<br>59. Equivalence and Noninferiority: Design, Measures, Classic Example<br>60. Adaptive Design Measures<br>61. Randomization: Fixed or Adaptive Procedures<br>62. Blinding: Who, When, and and How?<br>63. Multicenter Consideration<br>64. Phase 0 Trials: Window of Opportunity<br>65. Registries<br>66. Phases of Clinical Trials<br>67. IDEAL Framework</p><p>CLINICAL PREPARATION<br>68. Patient Perspectives<br>69. Budgeting<br>70. Ethics and Review Boards<br>71. Regulatory Considerations for Sports Medicine Technologies: New Drugs and Medical Devices<br>72. Funding Approaches<br>73. Conflicts of Interest<br>74. Subject Recruitment<br>75. Data Management<br>76. A Practical Guide to Conducting Research in the Acute Setting<br>77. Special Populatoins<br>78. Subject Adherence<br>79. Time-to-Event Outcomes and Survival Analysis<br>80. Monitoring Committee in Clinical Trials<br><br>REGULATORY BASICS<br>81. FDA Overview<br>82. Investigational New Drug (IND) Application<br>83. New Drug Application<br>84. Medical Devices<br>85. Radiation-emitting Electronic Products<br>86. Orphan Drugs<br>87. Biological Drugs<br>88. Combination Products<br>89. Cosmetics in Sports Medicine<br>90. CMC and GxP<br>91. Non-US Regulatory<br>92. Post-Market Drug Safety Monitoring<br>93. Post-Market Device Safety Monitoring</p><p>CLINICAL IMPLEMENTATION<br>94. Implementation Research<br>95. Design and Analysis<br>96. Mixed-methods Research<br>97. Implementation of Multimodal Concussion Research Within Military Medical Environments<br>98. Guideline Development</p><p>PUBLIC HEALTH<br>99. Public Health<br>100. Edpidemiology of Sports Injuries<br>101. Factors<br>102. Good Questions<br>103. Population and Environmental Specific Considerations<br>104. Law, Policy, and Ethics<br>105. Healthcare Institutions and Systems<br>106. Public Health Institutions and Systems</p><p>PRACTICAL RESOURCES<br>107. Presenting Data<br>108. Manuscript Preparation<br>109. Promoting Research<br>110. Quality Improvement<br>111. Team Science and Building a Team<br>112. Types of Intellectual Property<br>113. Venture Pathways<br>114. Utilizing National Institutes of Health (NIH) Grants to Fund Translational Research<br>115. Sample Forms and Templates</p>