Translational Plastic Surgery provides a comprehensive overview reflecting the depth and breadth of the field of translational research focused on plastic surgery, with input from a distinguished team of basic and clinical investigators. 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 plastic surgery research, 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.
1. Part I. Introduction - p. P1 2. Chapter 1. Introduction - p. 3 3. Chapter 2. The translational process - p. 5 4. Chapter 3. The scientific method—updated to the 21st century - p. 11 5. Chapter 4. Basic research - p. 15 6. Part II. Pre-clinical - p. P2 7. Chapter 5. Overview of preclinical research - p. 21 8. Chapter 6. What problem are you solving? - p. 25 9. Chapter 7. Introduction to drugs, devices, and testing - p. 29 10. Chapter 8. Drug discovery in plastic surgery - p. 35 11. Chapter 9. Drug testing - p. 45 12. Chapter 10. Device discovery and prototyping - p. 51 13. Chapter 11. Device testing - p. 55 14. Chapter 12. Diagnostic discovery - p. 59 15. Chapter 13. Diagnostic testing - p. 65 16. Chapter 14. Other product types - p. 73 17. Chapter 15. Procedural technique development - p. 77 18. Chapter 16. Behavioral interventions - p. 83 19. Chapter 17. Artificial intelligence - p. 87 20. Part III. Clinical: Fundamentals - p. P3 21. Chapter 18. Introduction to clinical research: What is it? Why is it needed? - p. 93 22. Chapter 19. The question: Types of research questions and how to develop them - p. 97 23. Chapter 20. Study population: Who and why them? - p. 103 24. Chapter 21. Outcome measures: What data are being collected and why? - p. 107 25. Chapter 22. Optimizing the question: Balancing significance and feasibility - p. 113 26. Part IV. Statistical principles - p. P4 27. Chapter 23. Common issues in analysis - p. 119 28. Chapter 24. Distributions - p. 123 29. Chapter 25. Hypotheses and error types - p. 127 30. Chapter 26. Power - p. 131 31. Chapter 27. Regression - p. 135 32. Chapter 28. Continuous variable analysis: t-test, Mann-Whitney U, and Wilcoxon Rank - p. 139 33. Chapter 29. Categorical variable analyses: Chi-square, Fisher exact, and Mantel-Haenszel tests - p. 143 34. Chapter 30. Analysis of variance - p. 149 35. Chapter 31. Correlation - p. 153 36. Chapter 32. Basic science statistics - p. 157 37. Chapter 33. Sample size - p. 163 38. Chapter 34. Statistical software packages for the clinician scientist - p. 167 39. Part V. Clinical - p. P5 40. Chapter 35. Design principles: Hierarchy of study types - p. 173 41. Chapter 36. Case series: Design, measures, and classic example - p. 177 42. Chapter 37. Case-control study: Design, measures, and classic example - p. 181 43. Chapter 38. Cohort studies: Design, measures, examples, and limitations - p. 187 44. Chapter 39. Fundamentals of cross-sectional study design: Metrics and landmark applications in plastic surgery - p. 191 45. Chapter 40. Longitudinal study: Design, measures, and classic example - p. 195 46. Chapter 41. Meta-analysis: Design, measures, and classic example - p. 199 47. Chapter 42. Cost-effectiveness study: design, measures, and classic example - p. 205 48. Chapter 43. Diagnostic test evaluation: Design, measures, and classic example - p. 211 49. Chapter 44. Reliability study: Design, measures, and classic example - p. 215 50. Chapter 45. Understanding database studies - p. 219 51. Chapter 46. Surveys and questionnaires: Design, measures, and classic example - p. 223 52. Chapter 47. Qualitative and mixed methodologies - p. 227 53. Part VI. Clinical trials - p. P6 54. Chapter 48. The challenges of conducting randomized controlled trials in plastic surgery: Overcoming the ethical and practical barriers - p. 233 55. Chapter 49. Nonrandomized controlled trials: Design, measures, and classic examples - p. 237 56. Chapter 50. Historical control: Design, measures, classical example - p. 241 57. Chapter 51. Cross-over: Designs, measures, and examples - p. 245 58. Chapter 52. Withdrawal studies: Design, measures, and classic example - p. 249 59. Chapter 53. Factorial design: Design, measures, classic example - p. 253 60. Chapter 54. Cluster randomized trials - p. 259 61. Chapter 55. Hybrid design: Design, measures, classic example - p. 265 62. Chapter 56. Large, pragmatic trials: Design, measures, and classic examples - p. 269 63. Chapter 57. Equivalence and noninferiority: design, measures, and classic examples - p. 275 64. Chapter 58. Group allocation: Design, measures, classic examples - p. 281 65. Chapter 59. Randomization: Fixed or adaptive procedures - p. 287 66. Chapter 60. Blinding: Who and how? - p. 291 67. Chapter 61. Multicenter considerations - p. 295 68. Chapter 62. Phase 0 trials - p. 303 69. Chapter 63. Registries - p. 307 70. Chapter 64. Phases of clinical trials - p. 315 71. Chapter 65. The IDEAL framework - p. 319 72. Part VII. Clinical: Preparation - p. P7 73. Chapter 66. Patient perspectives - p. 325 74. Chapter 67. Budgeting for research studies - p. 329 75. Chapter 68. Ethics and review board - p. 333 76. Chapter 69. Regulatory considerations for new drugs and devices - p. 337 77. Chapter 70. Conflicts of interest - p. 341 78. Chapter 71. Subject recruitment - p. 347 79. Chapter 72. Data management and subject recruitment - p. 351 80. Chapter 73. Quality control in plastic surgery research - p. 355 81. Chapter 74. Research in acute settings - p. 359 82. Chapter 75. Special populations - p. 365 83. Chapter 76. Report forms: Harm and quality of life - p. 371 84. Chapter 77. Subject adherence - p. 377 85. Chapter 78. Survival analysis - p. 381 86. Chapter 79. Monitoring committee in clinical trials - p. 385 87. Part VIII. Regulatory basics - p. P8 88. Chapter 80. The Food and Drug Administration—Function and organization - p. 391 89. Chapter 81. Investigational new drug application (IND) and new drug applications - p. 395 90. Chapter 82. Regulatory basics: Devices - p. 399 91. Chapter 83. Radiation-emitting electronic products - p. 407 92. Chapter 84. Non-US regulatory approval - p. 411 93. Chapter 85. Postmarket drug safety monitoring - p. 415 94. Chapter 86. FDA postmarket device safety monitoring - p. 419 95. Part IX. Clinical implementation - p. P9 96. Chapter 87. Implementation research - p. 425 97. Chapter 88. Design and analysis - p. 431 98. Chapter 89. Population- and setting-specific implementation - p. 439 99. Chapter 90. Clinical practice guideline development - p. 445 100. Part X. Public health - p. P10 101. Chapter 91. Public health and plastic surgery - p. 455 102. Chapter 92. Epidemiology in plastic surgery - p. 461 103. Chapter 93. Population and environmental-specific considerations in plastic surgery research - p. 469 104. Chapter 94. Law, policy, and ethics - p. 475 105. Chapter 95. Healthcare institutions and systems - p. 481 106. Chapter 96. Public health institutions and systems in plastic and reconstructive surgery - p. 489 107. Part XI. Practical resources - p. P11 108. Chapter 97. Presenting data - p. 497 109. Chapter 98. Manuscript preparation - p. 503 110. Chapter 99. Promoting research - p. 511 111. Chapter 100. Principles of quality improvement in plastic and reconstructive surgery - p. 517 112. Chapter 101. Team science and building a team - p. 523 113. Chapter 102. Patent basics - p. 529 114. Chapter 103. Venture pathways - p. 533 115. Chapter 104. SBIR/STTR: What they are, what they do, and how they work. Application components - p. 539 116. Chapter 105. Sample forms and templates - p. 545 117. Glossary - p. 549 118. Index - p. 565
Translational Plastic Surgery provides a comprehensive overview reflecting the depth and breadth of the field of translational research focused on plastic surgery, with input from a distinguished team of basic and clinical investigators. 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 plastic surgery research, 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.
1. Part I. Introduction - p. P1 2. Chapter 1. Introduction - p. 3 3. Chapter 2. The translational process - p. 5 4. Chapter 3. The scientific method—updated to the 21st century - p. 11 5. Chapter 4. Basic research - p. 15 6. Part II. Pre-clinical - p. P2 7. Chapter 5. Overview of preclinical research - p. 21 8. Chapter 6. What problem are you solving? - p. 25 9. Chapter 7. Introduction to drugs, devices, and testing - p. 29 10. Chapter 8. Drug discovery in plastic surgery - p. 35 11. Chapter 9. Drug testing - p. 45 12. Chapter 10. Device discovery and prototyping - p. 51 13. Chapter 11. Device testing - p. 55 14. Chapter 12. Diagnostic discovery - p. 59 15. Chapter 13. Diagnostic testing - p. 65 16. Chapter 14. Other product types - p. 73 17. Chapter 15. Procedural technique development - p. 77 18. Chapter 16. Behavioral interventions - p. 83 19. Chapter 17. Artificial intelligence - p. 87 20. Part III. Clinical: Fundamentals - p. P3 21. Chapter 18. Introduction to clinical research: What is it? Why is it needed? - p. 93 22. Chapter 19. The question: Types of research questions and how to develop them - p. 97 23. Chapter 20. Study population: Who and why them? - p. 103 24. Chapter 21. Outcome measures: What data are being collected and why? - p. 107 25. Chapter 22. Optimizing the question: Balancing significance and feasibility - p. 113 26. Part IV. Statistical principles - p. P4 27. Chapter 23. Common issues in analysis - p. 119 28. Chapter 24. Distributions - p. 123 29. Chapter 25. Hypotheses and error types - p. 127 30. Chapter 26. Power - p. 131 31. Chapter 27. Regression - p. 135 32. Chapter 28. Continuous variable analysis: t-test, Mann-Whitney U, and Wilcoxon Rank - p. 139 33. Chapter 29. Categorical variable analyses: Chi-square, Fisher exact, and Mantel-Haenszel tests - p. 143 34. Chapter 30. Analysis of variance - p. 149 35. Chapter 31. Correlation - p. 153 36. Chapter 32. Basic science statistics - p. 157 37. Chapter 33. Sample size - p. 163 38. Chapter 34. Statistical software packages for the clinician scientist - p. 167 39. Part V. Clinical - p. P5 40. Chapter 35. Design principles: Hierarchy of study types - p. 173 41. Chapter 36. Case series: Design, measures, and classic example - p. 177 42. Chapter 37. Case-control study: Design, measures, and classic example - p. 181 43. Chapter 38. Cohort studies: Design, measures, examples, and limitations - p. 187 44. Chapter 39. Fundamentals of cross-sectional study design: Metrics and landmark applications in plastic surgery - p. 191 45. Chapter 40. Longitudinal study: Design, measures, and classic example - p. 195 46. Chapter 41. Meta-analysis: Design, measures, and classic example - p. 199 47. Chapter 42. Cost-effectiveness study: design, measures, and classic example - p. 205 48. Chapter 43. Diagnostic test evaluation: Design, measures, and classic example - p. 211 49. Chapter 44. Reliability study: Design, measures, and classic example - p. 215 50. Chapter 45. Understanding database studies - p. 219 51. Chapter 46. Surveys and questionnaires: Design, measures, and classic example - p. 223 52. Chapter 47. Qualitative and mixed methodologies - p. 227 53. Part VI. Clinical trials - p. P6 54. Chapter 48. The challenges of conducting randomized controlled trials in plastic surgery: Overcoming the ethical and practical barriers - p. 233 55. Chapter 49. Nonrandomized controlled trials: Design, measures, and classic examples - p. 237 56. Chapter 50. Historical control: Design, measures, classical example - p. 241 57. Chapter 51. Cross-over: Designs, measures, and examples - p. 245 58. Chapter 52. Withdrawal studies: Design, measures, and classic example - p. 249 59. Chapter 53. Factorial design: Design, measures, classic example - p. 253 60. Chapter 54. Cluster randomized trials - p. 259 61. Chapter 55. Hybrid design: Design, measures, classic example - p. 265 62. Chapter 56. Large, pragmatic trials: Design, measures, and classic examples - p. 269 63. Chapter 57. Equivalence and noninferiority: design, measures, and classic examples - p. 275 64. Chapter 58. Group allocation: Design, measures, classic examples - p. 281 65. Chapter 59. Randomization: Fixed or adaptive procedures - p. 287 66. Chapter 60. Blinding: Who and how? - p. 291 67. Chapter 61. Multicenter considerations - p. 295 68. Chapter 62. Phase 0 trials - p. 303 69. Chapter 63. Registries - p. 307 70. Chapter 64. Phases of clinical trials - p. 315 71. Chapter 65. The IDEAL framework - p. 319 72. Part VII. Clinical: Preparation - p. P7 73. Chapter 66. Patient perspectives - p. 325 74. Chapter 67. Budgeting for research studies - p. 329 75. Chapter 68. Ethics and review board - p. 333 76. Chapter 69. Regulatory considerations for new drugs and devices - p. 337 77. Chapter 70. Conflicts of interest - p. 341 78. Chapter 71. Subject recruitment - p. 347 79. Chapter 72. Data management and subject recruitment - p. 351 80. Chapter 73. Quality control in plastic surgery research - p. 355 81. Chapter 74. Research in acute settings - p. 359 82. Chapter 75. Special populations - p. 365 83. Chapter 76. Report forms: Harm and quality of life - p. 371 84. Chapter 77. Subject adherence - p. 377 85. Chapter 78. Survival analysis - p. 381 86. Chapter 79. Monitoring committee in clinical trials - p. 385 87. Part VIII. Regulatory basics - p. P8 88. Chapter 80. The Food and Drug Administration—Function and organization - p. 391 89. Chapter 81. Investigational new drug application (IND) and new drug applications - p. 395 90. Chapter 82. Regulatory basics: Devices - p. 399 91. Chapter 83. Radiation-emitting electronic products - p. 407 92. Chapter 84. Non-US regulatory approval - p. 411 93. Chapter 85. Postmarket drug safety monitoring - p. 415 94. Chapter 86. FDA postmarket device safety monitoring - p. 419 95. Part IX. Clinical implementation - p. P9 96. Chapter 87. Implementation research - p. 425 97. Chapter 88. Design and analysis - p. 431 98. Chapter 89. Population- and setting-specific implementation - p. 439 99. Chapter 90. Clinical practice guideline development - p. 445 100. Part X. Public health - p. P10 101. Chapter 91. Public health and plastic surgery - p. 455 102. Chapter 92. Epidemiology in plastic surgery - p. 461 103. Chapter 93. Population and environmental-specific considerations in plastic surgery research - p. 469 104. Chapter 94. Law, policy, and ethics - p. 475 105. Chapter 95. Healthcare institutions and systems - p. 481 106. Chapter 96. Public health institutions and systems in plastic and reconstructive surgery - p. 489 107. Part XI. Practical resources - p. P11 108. Chapter 97. Presenting data - p. 497 109. Chapter 98. Manuscript preparation - p. 503 110. Chapter 99. Promoting research - p. 511 111. Chapter 100. Principles of quality improvement in plastic and reconstructive surgery - p. 517 112. Chapter 101. Team science and building a team - p. 523 113. Chapter 102. Patent basics - p. 529 114. Chapter 103. Venture pathways - p. 533 115. Chapter 104. SBIR/STTR: What they are, what they do, and how they work. Application components - p. 539 116. Chapter 105. Sample forms and templates - p. 545 117. Glossary - p. 549 118. Index - p. 565
