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. 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
1. Part I: Introduction - p. xix 2. Chapter 1. Introduction - p. 3 3. Chapter 2. The translational process - p. 5 4. Chapter 3. Scientific method - p. 9 5. Chapter 4. Basic research - p. 15 6. Part II: Pre-clinical - p. 22 7. Chapter 5. Overview of preclinical research - p. 25 8. Chapter 6. What problem are you solving? - p. 37 9. Chapter 7. Types of interventions: drugs, devices, diagnostic, procedural technique, and behavior change - p. 41 10. Chapter 8. Beyond drugs and surgery: a look at orthobiologics - p. 45 11. Chapter 9. Drug testing - p. 53 12. Chapter 10. Device discovery and prototyping - p. 57 13. Chapter 11. Device testing - p. 63 14. Chapter 12. Diagnostic discovery - p. 67 15. Chapter 13. Diagnostic testing - p. 71 16. Chapter 14. Preclinical: discussion of FDA product categories (what the FDA covers, regulated or not) - p. 75 17. Chapter 15. Procedural technique development - p. 79 18. Chapter 16. Behavioral intervention studies - p. 83 19. Chapter 17. Artificial intelligence - p. 87 20. Part III: Clinical: Fundamentals - p. 92 21. Chapter 18. Introduction to clinical research: what is it? why is it needed? - p. 95 22. Chapter 19. The question: types of research questions and how to develop them - p. 99 23. Chapter 20. Study population: who and why them? - p. 103 24. Chapter 21. Outcome measurements: what data is being collected and why? - p. 107 25. Chapter 22. Optimizing the question: balancing significance and feasibility - p. 111 26. Part IV: Statistical principles - p. 113 27. Chapter 23. Common issues in analysis - p. 117 28. Chapter 24. Basic statistical principles - p. 123 29. Chapter 25. Distribution - p. 129 30. Chapter 26. Research hypothesis and error types - p. 133 31. Chapter 27. Power - p. 137 32. Chapter 28. Multivariable regression models - p. 141 33. Chapter 29. How to choose appropriate bivariate test - p. 145 34. Chapter 30. Categorical variable analyses: chi-square, Fisher exact, Mantel–Haenszel - p. 151 35. Chapter 31. Analysis of variance: ANOVA - p. 157 36. Chapter 32. Correlation - p. 161 37. Chapter 33. Statistical bias - p. 163 38. Chapter 34. Basic science statistics - p. 165 39. Chapter 35. Sample size - p. 167 40. Chapter 36. Statistical software - p. 169 41. Part V: Clinical: Study types - p. 171 42. Chapter 37. Design principles: hierarchy of study types - p. 175 43. Chapter 38. Case series: design, measures, and an example - p. 179 44. Chapter 39. Case-control study - p. 183 45. Chapter 40. Cohort studies - p. 187 46. Chapter 41. Cross-section study - p. 191 47. Chapter 42. Longitudinal study: design, measures, classic example - p. 195 48. Chapter 43. Meta-analysis - p. 201 49. Chapter 44. Cost-effectiveness study: design, measures, classic example - p. 207 50. Chapter 45. Diagnostic test evaluation: design, measures, classic example - p. 213 51. Chapter 46. Reliability study: design, measures, classic example - p. 217 52. Chapter 47. Database types and basic data management design principles for healthcare research - p. 225 53. Chapter 48. Survey studies and questionnaires - p. 229 54. Chapter 49. Qualitative methods and mixed methods - p. 233 55. Part VI: Clinical: Trials - p. 241 56. Chapter 50. Randomized controlled trials - p. 245 57. Chapter 51. Nonrandomized controlled trials - p. 251 58. Chapter 52. Historical control: design, measures, classic example - p. 255 59. Chapter 53. Crossover studies - p. 259 60. Chapter 54. Withdrawal studies: design, measures, classic example - p. 265 61. Chapter 55. Factorial design: design, measures, classic example - p. 269 62. Chapter 56. Group or cluster controlled trials: design, measures, classic example - p. 275 63. Chapter 57. Hybrid design: design, measures, classic examples - p. 279 64. Chapter 58. Large, pragmatic clinical trials - p. 287 65. Chapter 59. Equivalence and noninferiority: design, measures, classic example - p. 291 66. Chapter 60. Translational sports medicine: handbook for designing and conducting clinical and translational research - p. 295 67. Chapter 61. Randomization: fixed or adaptive procedures - p. 301 68. Chapter 62. Blinding: who, when and how? importance and impact on findings - p. 307 69. Chapter 63. Multicenter considerations - p. 311 70. Chapter 64. Phase 0 trials: window of opportunity - p. 317 71. Chapter 65. Registries - p. 323 72. Chapter 66. Phases of clinical trails - p. 331 73. Chapter 67. IDEAL framework: framework for describing the stages of innovation in surgery - p. 335 74. Part VII: Clinical preparation - p. 337 75. Chapter 68. Patient perspectives - p. 341 76. Chapter 69. Budgeting - p. 347 77. Chapter 70. Ethics and review boards - p. 351 78. Chapter 71. Regulatory considerations for sports medicine technologies: new drugs and medical devices - p. 357 79. Chapter 72. Funding approaches - p. 363 80. Chapter 73. Conflicts of interest - p. 367 81. Chapter 74. Subject recruitment - p. 371 82. Chapter 75. Data management: how to manage data safely and effectively in an organized manner - p. 377 83. Chapter 76. A practical guide to conducting research in the acute setting - p. 383 84. Chapter 77. Special populations - p. 389 85. Chapter 78. Subject adherence - p. 395 86. Chapter 79. Time-to-event outcomes and survival analysis - p. 401 87. Chapter 80. Monitoring committee in clinical trials - p. 407 88. Part VIII: Regulatory basics - p. 410 89. Chapter 81. FDA overview - p. 413 90. Chapter 82. Investigational new drug (IND) application - p. 419 91. Chapter 83. New drug application - p. 425 92. Chapter 84. Medical devices - p. 429 93. Chapter 85. Radiation-emitting electronic products - p. 433 94. Chapter 86. Orphan drugs - p. 439 95. Chapter 87. Biological drugs - p. 443 96. Chapter 88. Combination products - p. 447 97. Chapter 89. Cosmetics in sports medicine - p. 453 98. Chapter 90. CMC and GxP: chemistry, manufacturing, and controls & good practice' guidelines and regulations - p. 455 99. Chapter 91. Non-US regulatory - p. 457 100. Chapter 92. Postmarket drug safety monitoring - p. 459 101. Chapter 93. Postmarket device safety monitoring - p. 463 102. Part IX: Clinical implementation - p. 466 103. Chapter 94. Implementation research - p. 469 104. Chapter 95. Design and analysis - p. 473 105. Chapter 96. Mixed methods in concussion research - p. 479 106. Chapter 97. Implementation of multimodal concussion research within military medical environments - p. 483 107. Chapter 98. Guideline development - p. 489 108. Part X: Public health - p. 493 109. Chapter 99. Public health - p. 497 110. Chapter 100. Epidemiology of sports injuries - p. 501 111. Chapter 101. Factors - p. 505 112. Chapter 102. Good questions—asking the right public health questions - p. 509 113. Chapter 103. Population- and environmental-specific considerations - p. 513 114. Chapter 104. Law, policy, and ethics - p. 519 115. Chapter 105. Healthcare institutions and systems - p. 525 116. Chapter 106. Public health institutions and systems - p. 529 117. Part XI: Practical resources - p. 532 118. Chapter 107. Presenting data - p. 535 119. Chapter 108. Manuscript preparation - p. 537 120. Chapter 109. Promoting research - p. 541 121. Chapter 110. Quality improvement - p. 547 122. Chapter 111. Team science and building a team - p. 551 123. Chapter 112. Types of intellectual property - p. 557 124. Chapter 113. Venture pathways - p. 561 125. Chapter 114. Utilizing National Institutes of Health (NIH) grants to fund translational research: An Overview - p. 567 126. Chapter 115. Sample forms and templates - p. 571 127. Glossary - p. 577 128. Index - p. 591
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. 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
1. Part I: Introduction - p. xix 2. Chapter 1. Introduction - p. 3 3. Chapter 2. The translational process - p. 5 4. Chapter 3. Scientific method - p. 9 5. Chapter 4. Basic research - p. 15 6. Part II: Pre-clinical - p. 22 7. Chapter 5. Overview of preclinical research - p. 25 8. Chapter 6. What problem are you solving? - p. 37 9. Chapter 7. Types of interventions: drugs, devices, diagnostic, procedural technique, and behavior change - p. 41 10. Chapter 8. Beyond drugs and surgery: a look at orthobiologics - p. 45 11. Chapter 9. Drug testing - p. 53 12. Chapter 10. Device discovery and prototyping - p. 57 13. Chapter 11. Device testing - p. 63 14. Chapter 12. Diagnostic discovery - p. 67 15. Chapter 13. Diagnostic testing - p. 71 16. Chapter 14. Preclinical: discussion of FDA product categories (what the FDA covers, regulated or not) - p. 75 17. Chapter 15. Procedural technique development - p. 79 18. Chapter 16. Behavioral intervention studies - p. 83 19. Chapter 17. Artificial intelligence - p. 87 20. Part III: Clinical: Fundamentals - p. 92 21. Chapter 18. Introduction to clinical research: what is it? why is it needed? - p. 95 22. Chapter 19. The question: types of research questions and how to develop them - p. 99 23. Chapter 20. Study population: who and why them? - p. 103 24. Chapter 21. Outcome measurements: what data is being collected and why? - p. 107 25. Chapter 22. Optimizing the question: balancing significance and feasibility - p. 111 26. Part IV: Statistical principles - p. 113 27. Chapter 23. Common issues in analysis - p. 117 28. Chapter 24. Basic statistical principles - p. 123 29. Chapter 25. Distribution - p. 129 30. Chapter 26. Research hypothesis and error types - p. 133 31. Chapter 27. Power - p. 137 32. Chapter 28. Multivariable regression models - p. 141 33. Chapter 29. How to choose appropriate bivariate test - p. 145 34. Chapter 30. Categorical variable analyses: chi-square, Fisher exact, Mantel–Haenszel - p. 151 35. Chapter 31. Analysis of variance: ANOVA - p. 157 36. Chapter 32. Correlation - p. 161 37. Chapter 33. Statistical bias - p. 163 38. Chapter 34. Basic science statistics - p. 165 39. Chapter 35. Sample size - p. 167 40. Chapter 36. Statistical software - p. 169 41. Part V: Clinical: Study types - p. 171 42. Chapter 37. Design principles: hierarchy of study types - p. 175 43. Chapter 38. Case series: design, measures, and an example - p. 179 44. Chapter 39. Case-control study - p. 183 45. Chapter 40. Cohort studies - p. 187 46. Chapter 41. Cross-section study - p. 191 47. Chapter 42. Longitudinal study: design, measures, classic example - p. 195 48. Chapter 43. Meta-analysis - p. 201 49. Chapter 44. Cost-effectiveness study: design, measures, classic example - p. 207 50. Chapter 45. Diagnostic test evaluation: design, measures, classic example - p. 213 51. Chapter 46. Reliability study: design, measures, classic example - p. 217 52. Chapter 47. Database types and basic data management design principles for healthcare research - p. 225 53. Chapter 48. Survey studies and questionnaires - p. 229 54. Chapter 49. Qualitative methods and mixed methods - p. 233 55. Part VI: Clinical: Trials - p. 241 56. Chapter 50. Randomized controlled trials - p. 245 57. Chapter 51. Nonrandomized controlled trials - p. 251 58. Chapter 52. Historical control: design, measures, classic example - p. 255 59. Chapter 53. Crossover studies - p. 259 60. Chapter 54. Withdrawal studies: design, measures, classic example - p. 265 61. Chapter 55. Factorial design: design, measures, classic example - p. 269 62. Chapter 56. Group or cluster controlled trials: design, measures, classic example - p. 275 63. Chapter 57. Hybrid design: design, measures, classic examples - p. 279 64. Chapter 58. Large, pragmatic clinical trials - p. 287 65. Chapter 59. Equivalence and noninferiority: design, measures, classic example - p. 291 66. Chapter 60. Translational sports medicine: handbook for designing and conducting clinical and translational research - p. 295 67. Chapter 61. Randomization: fixed or adaptive procedures - p. 301 68. Chapter 62. Blinding: who, when and how? importance and impact on findings - p. 307 69. Chapter 63. Multicenter considerations - p. 311 70. Chapter 64. Phase 0 trials: window of opportunity - p. 317 71. Chapter 65. Registries - p. 323 72. Chapter 66. Phases of clinical trails - p. 331 73. Chapter 67. IDEAL framework: framework for describing the stages of innovation in surgery - p. 335 74. Part VII: Clinical preparation - p. 337 75. Chapter 68. Patient perspectives - p. 341 76. Chapter 69. Budgeting - p. 347 77. Chapter 70. Ethics and review boards - p. 351 78. Chapter 71. Regulatory considerations for sports medicine technologies: new drugs and medical devices - p. 357 79. Chapter 72. Funding approaches - p. 363 80. Chapter 73. Conflicts of interest - p. 367 81. Chapter 74. Subject recruitment - p. 371 82. Chapter 75. Data management: how to manage data safely and effectively in an organized manner - p. 377 83. Chapter 76. A practical guide to conducting research in the acute setting - p. 383 84. Chapter 77. Special populations - p. 389 85. Chapter 78. Subject adherence - p. 395 86. Chapter 79. Time-to-event outcomes and survival analysis - p. 401 87. Chapter 80. Monitoring committee in clinical trials - p. 407 88. Part VIII: Regulatory basics - p. 410 89. Chapter 81. FDA overview - p. 413 90. Chapter 82. Investigational new drug (IND) application - p. 419 91. Chapter 83. New drug application - p. 425 92. Chapter 84. Medical devices - p. 429 93. Chapter 85. Radiation-emitting electronic products - p. 433 94. Chapter 86. Orphan drugs - p. 439 95. Chapter 87. Biological drugs - p. 443 96. Chapter 88. Combination products - p. 447 97. Chapter 89. Cosmetics in sports medicine - p. 453 98. Chapter 90. CMC and GxP: chemistry, manufacturing, and controls & good practice' guidelines and regulations - p. 455 99. Chapter 91. Non-US regulatory - p. 457 100. Chapter 92. Postmarket drug safety monitoring - p. 459 101. Chapter 93. Postmarket device safety monitoring - p. 463 102. Part IX: Clinical implementation - p. 466 103. Chapter 94. Implementation research - p. 469 104. Chapter 95. Design and analysis - p. 473 105. Chapter 96. Mixed methods in concussion research - p. 479 106. Chapter 97. Implementation of multimodal concussion research within military medical environments - p. 483 107. Chapter 98. Guideline development - p. 489 108. Part X: Public health - p. 493 109. Chapter 99. Public health - p. 497 110. Chapter 100. Epidemiology of sports injuries - p. 501 111. Chapter 101. Factors - p. 505 112. Chapter 102. Good questions—asking the right public health questions - p. 509 113. Chapter 103. Population- and environmental-specific considerations - p. 513 114. Chapter 104. Law, policy, and ethics - p. 519 115. Chapter 105. Healthcare institutions and systems - p. 525 116. Chapter 106. Public health institutions and systems - p. 529 117. Part XI: Practical resources - p. 532 118. Chapter 107. Presenting data - p. 535 119. Chapter 108. Manuscript preparation - p. 537 120. Chapter 109. Promoting research - p. 541 121. Chapter 110. Quality improvement - p. 547 122. Chapter 111. Team science and building a team - p. 551 123. Chapter 112. Types of intellectual property - p. 557 124. Chapter 113. Venture pathways - p. 561 125. Chapter 114. Utilizing National Institutes of Health (NIH) grants to fund translational research: An Overview - p. 567 126. Chapter 115. Sample forms and templates - p. 571 127. Glossary - p. 577 128. Index - p. 591
