Translational Orthopedics: Designing and Conducting Translational Research covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader 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.
1. Chapter 1 : Introduction - p. Page x 2. Chapter 2 : Translational process - p. Page 6 3. Chapter 3 : Scientific method - p. Page 11 4. Chapter 4 : Basic research - p. Page 15 5. Chapter 5 : Overview of preclinical research - p. Page 18 6. Chapter 6 : Formulating a researchable question: a critical step for facilitating good clinical research - p. Page 24 7. Chapter 7 : Types of interventions: drug, device, diagnostic, procedural technique, or behavior change - p. Page 27 8. Chapter 8 : Drug discovery - p. Page 30 9. Chapter 9 : Drug testing - p. Page 37 10. Chapter 10 : Device discovery and prototyping - p. Page 44 11. Chapter 11 : Device testing - p. Page 51 12. Chapter 12 : Diagnostic discovery - p. Page 57 13. Chapter 13 : Diagnostic testing - p. Page 63 14. Chapter 14 : Other product types - p. Page 73 15. Chapter 15 : Procedural technique development - p. Page 78 16. Chapter 16 : Behavioral intervention - p. Page 81 17. Chapter 17 : Introduction to clinical research - p. Page 85 18. Chapter 18 : The question - p. Page 92 19. Chapter 19 : Study population - p. Page 95 20. Chapter 20 : Outcome measurements - p. Page 100 21. Chapter 21 : Optimizing the question: Balancing significance and feasibility - p. Page 105 22. Chapter 22 : Common issues in analysis - p. Page 110 23. Chapter 23 : Basic statistical principles - p. Page 114 24. Chapter 24 : Distributions - p. Page 121 25. Chapter 25 : Hypotheses and error types - p. Page 127 26. Chapter 26 : Power - p. Page 132 27. Chapter 27 : Regression - p. Page 134 28. Chapter 28 : Continuous variable analyses - p. Page 140 29. Chapter 29 : Categorical variable analyses - p. Page 145 30. Chapter 30 : Analysis of variance - p. Page 149 31. Chapter 31 : Correlation - p. Page 153 32. Chapter 32 : Biases - p. Page 157 33. Chapter 33 : Basic science statistics - p. Page 162 34. Chapter 34 : Design principles - p. Page 166 35. Chapter 35 : Case series - p. Page 171 36. Chapter 36 : Case control study - p. Page 175 37. Chapter 37 : Cohort study - p. Page 180 38. Chapter 38 : Cross-sectional study - p. Page 183 39. Chapter 39 : Longitudinal study - p. Page 190 40. Chapter 40 : Clinical trials - p. Page 192 41. Chapter 41 : Meta-analysis - p. Page 195 42. Chapter 42 : Cost-effectiveness study - p. Page 201 43. Chapter 43 : Diagnostic test evaluation - p. Page 206 44. Chapter 44 : Reliability study - p. Page 214 45. Chapter 45 : Database studies - p. Page 217 46. Chapter 46 : Surveys and questionnaires - p. Page 222 47. Chapter 47 : Qualitative and mixed methods - p. Page 227 48. Chapter 48 : Randomized controlled study - p. Page 231 49. Chapter 49 : Nonrandomized controlled study - p. Page 240 50. Chapter 50 : Historical control - p. Page 248 51. Chapter 51 : Cross-over - p. Page 251 52. Chapter 52 : Withdrawal studies: Design, measures, classic example - p. Page 254 53. Chapter 53 : Factorial design - p. Page 260 54. Chapter 54 : Group allocation - p. Page 263 55. Chapter 55 : Hybrid design - p. Page 267 56. Chapter 56 : Large pragmatic studies - p. Page 271 57. Chapter 57 : An overview of adaptive clinical trials - p. Page 274 58. Chapter 58 : Randomization - p. Page 278 59. Chapter 59 : Blinding - p. Page 281 60. Chapter 60 : Multicenter considerations - p. Page 285 61. Chapter 61 : Registries - p. Page 289 62. Chapter 62 : Phases of clinical trials - p. Page 294 63. Chapter 63 : The IDEAL framework - p. Page 298 64. Chapter 64 : Artificial intelligence - p. Page 303 65. Chapter 65 : Patient perspectives - p. Page 308 66. Chapter 66 : Sample size - p. Page 315 67. Chapter 67 : Budgeting - p. Page 322 68. Chapter 68 : Ethics and review boards - p. Page 327 69. Chapter 69 : Regulatory considerations for new drugs and devices - p. Page 331 70. Chapter 70 : Funding approaches - p. Page 336 71. Chapter 71 : Subject recruitment - p. Page 341 72. Chapter 72 : Data management - p. Page 347 73. Chapter 73 : Statistical software - p. Page 351 74. Chapter 74 : Report forms - p. Page 357 75. Chapter 75 : Subject adherence - p. Page 361 76. Chapter 76 : Survival analysis - p. Page 364 77. Chapter 77 : Monitoring committee in clinical trials - p. Page 370 78. Chapter 78 : The Food and Drug Administration - p. Page 372 79. Chapter 79 : IND - p. Page 379 80. Chapter 80 : New drug application - p. Page 386 81. Chapter 81 : Devices - p. Page 389 82. Chapter 82 : Radiation-emitting electronic products - p. Page 395 83. Chapter 83 : Orphan drugs - p. Page 400 84. Chapter 84 : Orthopedics journal: biologics - p. Page 406 85. Chapter 85 : Combination products - p. Page 410 86. Chapter 86 : Foods - p. Page 414 87. Chapter 87 : Cosmetics - p. Page 419 88. Chapter 88 : CMC and GxP - p. Page 425 89. Chapter 89 : Non-US regulatory guidelines - p. Page 429 90. Chapter 90 : Post-market drug safety monitoring - p. Page 434 91. Chapter 91 : Postmarket device safety monitoring - p. Page 437 92. Chapter 92 : Implementation research - p. Page 443 93. Chapter 93 : Design and analysis - p. Page 449 94. Chapter 94 : Mixed methods research in implementation science - p. Page 452 95. Chapter 95 : Population and setting-specific implementation - p. Page 458 96. Chapter 96 : Public health - p. Page 463 97. Chapter 97 : Epidemiology - p. Page 469 98. Chapter 98 : Public health factors - p. Page 473 99. Chapter 99 : Good questions - p. Page 477 100. Chapter 100 : Population- and environmental-specific considerations - p. Page 481 101. Chapter 101 : Public health: Law policy and ethics - p. Page 486 102. Chapter 102 : Healthcare institutions and systems - p. Page 490 103. Chapter 103 : Public health institutions and systems - p. Page 494 104. Chapter 104 : Presenting data - p. Page 497 105. Chapter 105 : Manuscript preparation - p. Page 505 106. Chapter 106 : Building a team - p. Page 512 107. Chapter 107 : Patent basics - p. Page 516 108. Chapter 108 : Venture pathways - p. Page 520 109. Chapter 109 : SBIR and STTR programs - p. Page 523 110. Chapter 110 : Sample forms and templates - p. Page 528 111. Glossary - p. Page 533 112. Index - p. Page 548
Translational Orthopedics: Designing and Conducting Translational Research covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader 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.
1. Chapter 1 : Introduction - p. Page x 2. Chapter 2 : Translational process - p. Page 6 3. Chapter 3 : Scientific method - p. Page 11 4. Chapter 4 : Basic research - p. Page 15 5. Chapter 5 : Overview of preclinical research - p. Page 18 6. Chapter 6 : Formulating a researchable question: a critical step for facilitating good clinical research - p. Page 24 7. Chapter 7 : Types of interventions: drug, device, diagnostic, procedural technique, or behavior change - p. Page 27 8. Chapter 8 : Drug discovery - p. Page 30 9. Chapter 9 : Drug testing - p. Page 37 10. Chapter 10 : Device discovery and prototyping - p. Page 44 11. Chapter 11 : Device testing - p. Page 51 12. Chapter 12 : Diagnostic discovery - p. Page 57 13. Chapter 13 : Diagnostic testing - p. Page 63 14. Chapter 14 : Other product types - p. Page 73 15. Chapter 15 : Procedural technique development - p. Page 78 16. Chapter 16 : Behavioral intervention - p. Page 81 17. Chapter 17 : Introduction to clinical research - p. Page 85 18. Chapter 18 : The question - p. Page 92 19. Chapter 19 : Study population - p. Page 95 20. Chapter 20 : Outcome measurements - p. Page 100 21. Chapter 21 : Optimizing the question: Balancing significance and feasibility - p. Page 105 22. Chapter 22 : Common issues in analysis - p. Page 110 23. Chapter 23 : Basic statistical principles - p. Page 114 24. Chapter 24 : Distributions - p. Page 121 25. Chapter 25 : Hypotheses and error types - p. Page 127 26. Chapter 26 : Power - p. Page 132 27. Chapter 27 : Regression - p. Page 134 28. Chapter 28 : Continuous variable analyses - p. Page 140 29. Chapter 29 : Categorical variable analyses - p. Page 145 30. Chapter 30 : Analysis of variance - p. Page 149 31. Chapter 31 : Correlation - p. Page 153 32. Chapter 32 : Biases - p. Page 157 33. Chapter 33 : Basic science statistics - p. Page 162 34. Chapter 34 : Design principles - p. Page 166 35. Chapter 35 : Case series - p. Page 171 36. Chapter 36 : Case control study - p. Page 175 37. Chapter 37 : Cohort study - p. Page 180 38. Chapter 38 : Cross-sectional study - p. Page 183 39. Chapter 39 : Longitudinal study - p. Page 190 40. Chapter 40 : Clinical trials - p. Page 192 41. Chapter 41 : Meta-analysis - p. Page 195 42. Chapter 42 : Cost-effectiveness study - p. Page 201 43. Chapter 43 : Diagnostic test evaluation - p. Page 206 44. Chapter 44 : Reliability study - p. Page 214 45. Chapter 45 : Database studies - p. Page 217 46. Chapter 46 : Surveys and questionnaires - p. Page 222 47. Chapter 47 : Qualitative and mixed methods - p. Page 227 48. Chapter 48 : Randomized controlled study - p. Page 231 49. Chapter 49 : Nonrandomized controlled study - p. Page 240 50. Chapter 50 : Historical control - p. Page 248 51. Chapter 51 : Cross-over - p. Page 251 52. Chapter 52 : Withdrawal studies: Design, measures, classic example - p. Page 254 53. Chapter 53 : Factorial design - p. Page 260 54. Chapter 54 : Group allocation - p. Page 263 55. Chapter 55 : Hybrid design - p. Page 267 56. Chapter 56 : Large pragmatic studies - p. Page 271 57. Chapter 57 : An overview of adaptive clinical trials - p. Page 274 58. Chapter 58 : Randomization - p. Page 278 59. Chapter 59 : Blinding - p. Page 281 60. Chapter 60 : Multicenter considerations - p. Page 285 61. Chapter 61 : Registries - p. Page 289 62. Chapter 62 : Phases of clinical trials - p. Page 294 63. Chapter 63 : The IDEAL framework - p. Page 298 64. Chapter 64 : Artificial intelligence - p. Page 303 65. Chapter 65 : Patient perspectives - p. Page 308 66. Chapter 66 : Sample size - p. Page 315 67. Chapter 67 : Budgeting - p. Page 322 68. Chapter 68 : Ethics and review boards - p. Page 327 69. Chapter 69 : Regulatory considerations for new drugs and devices - p. Page 331 70. Chapter 70 : Funding approaches - p. Page 336 71. Chapter 71 : Subject recruitment - p. Page 341 72. Chapter 72 : Data management - p. Page 347 73. Chapter 73 : Statistical software - p. Page 351 74. Chapter 74 : Report forms - p. Page 357 75. Chapter 75 : Subject adherence - p. Page 361 76. Chapter 76 : Survival analysis - p. Page 364 77. Chapter 77 : Monitoring committee in clinical trials - p. Page 370 78. Chapter 78 : The Food and Drug Administration - p. Page 372 79. Chapter 79 : IND - p. Page 379 80. Chapter 80 : New drug application - p. Page 386 81. Chapter 81 : Devices - p. Page 389 82. Chapter 82 : Radiation-emitting electronic products - p. Page 395 83. Chapter 83 : Orphan drugs - p. Page 400 84. Chapter 84 : Orthopedics journal: biologics - p. Page 406 85. Chapter 85 : Combination products - p. Page 410 86. Chapter 86 : Foods - p. Page 414 87. Chapter 87 : Cosmetics - p. Page 419 88. Chapter 88 : CMC and GxP - p. Page 425 89. Chapter 89 : Non-US regulatory guidelines - p. Page 429 90. Chapter 90 : Post-market drug safety monitoring - p. Page 434 91. Chapter 91 : Postmarket device safety monitoring - p. Page 437 92. Chapter 92 : Implementation research - p. Page 443 93. Chapter 93 : Design and analysis - p. Page 449 94. Chapter 94 : Mixed methods research in implementation science - p. Page 452 95. Chapter 95 : Population and setting-specific implementation - p. Page 458 96. Chapter 96 : Public health - p. Page 463 97. Chapter 97 : Epidemiology - p. Page 469 98. Chapter 98 : Public health factors - p. Page 473 99. Chapter 99 : Good questions - p. Page 477 100. Chapter 100 : Population- and environmental-specific considerations - p. Page 481 101. Chapter 101 : Public health: Law policy and ethics - p. Page 486 102. Chapter 102 : Healthcare institutions and systems - p. Page 490 103. Chapter 103 : Public health institutions and systems - p. Page 494 104. Chapter 104 : Presenting data - p. Page 497 105. Chapter 105 : Manuscript preparation - p. Page 505 106. Chapter 106 : Building a team - p. Page 512 107. Chapter 107 : Patent basics - p. Page 516 108. Chapter 108 : Venture pathways - p. Page 520 109. Chapter 109 : SBIR and STTR programs - p. Page 523 110. Chapter 110 : Sample forms and templates - p. Page 528 111. Glossary - p. Page 533 112. Index - p. Page 548
