Translational Urology 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 urology, and know what is needed for successful collaboration. Further, this title is an indispensable tool in grant writing and funding efforts.
This 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 urology, 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.
1. Part I. Introduction - p. P1 2. Chapter 1. Introduction - p. 3 3. Chapter 2. Translational process - p. 5 4. Chapter 3. Scientific methods - p. 9 5. Chapter 4. Basic science - p. 13 6. Part II. Pre-clinical - p. P2 7. Chapter 5. Overview of preclinical research - p. 21 8. Chapter 6. Preclinical: What problem are you solving? - p. 25 9. Chapter 7. Types of interventions - p. 31 10. Chapter 8. Drug screening - p. 35 11. Chapter 9. Drug testing - p. 39 12. Chapter 10. Device discovery and prototyping - p. 43 13. Chapter 11. Device testing and regulatory approval - p. 47 14. Chapter 12. Other product types - p. 51 15. Chapter 13. Procedural technique development - p. 55 16. Chapter 14. Behavioral intervention - p. 59 17. Part III. Clinical: Fundamentals - p. P3 18. Chapter 15. Introduction to clinical research: What is it? Why is it needed? - p. 65 19. Chapter 16. Study population: Who and why? - p. 69 20. Chapter 17. Outcome measurements: What data are being collected and why? - p. 73 21. Part IV. Statistical principles - p. P4 22. Chapter 18. Common issues in analysis - p. 81 23. Chapter 19. Basic statistical principles - p. 85 24. Chapter 20. Hypotheses and error types - p. 95 25. Chapter 21. Power - p. 99 26. Chapter 22. Regression - p. 105 27. Chapter 23. Continuous variable analyses: Student's t-test, rank-sum test, and signed-rank test - p. 109 28. Chapter 24. Categorical variable analyses: Chi-square, Fisher exact, and Mantel–Haenszel - p. 115 29. Chapter 25. Analysis of variance - p. 121 30. Chapter 26. Correlation - p. 125 31. Chapter 27. Basic science statistics - p. 131 32. Part V. Clinical: Study types - p. P5 33. Chapter 28. Design principles: Hierarchy of study types - p. 137 34. Chapter 29. Case series: Design, measures, and classic example - p. 141 35. Chapter 30. Case-control study: Design, measures, classic example - p. 145 36. Chapter 31. Cohort study: Design, measures, classic example - p. 149 37. Chapter 32. Cross-sectional study: Design, measures, and classic examples - p. 153 38. Chapter 33. Longitudinal study: Pros and cons, study design, and classic examples - p. 159 39. Chapter 34. Clinical trials: Getting started - p. 165 40. Chapter 35. Meta-analysis: Design, measures, and classic examples - p. 171 41. Chapter 36. Cost-effectiveness analysis: Design, measures, and classic example - p. 177 42. Chapter 37. Database research in urology - p. 185 43. Chapter 38. Surveys and questionnaires - p. 189 44. Chapter 39. Qualitative and mixed methods in urology - p. 195 45. Part VI. Clinical trials - p. P6 46. Chapter 40. Randomized controlled trials: Design, measures, and classic examples - p. 201 47. Chapter 41. Nonrandomized controlled clinical trial - p. 207 48. Chapter 42. Historical control: Design, measures, and classic example - p. 211 49. Chapter 43. Crossover studies - p. 217 50. Chapter 44. Withdrawal studies: Design, measures, and classic examples - p. 221 51. Chapter 45. Equivalence and noninferiority: Design, measures, and classic example - p. 225 52. Chapter 46. Randomization: Fixed or adaptive procedures - p. 229 53. Chapter 47. Blinding: Who and how? - p. 233 54. Chapter 48. Multicenter considerations - p. 245 55. Chapter 49. Phase 0 & window of opportunity clinical trials - p. 249 56. Chapter 50. IDEAL framework for surgical innovation - p. 255 57. Chapter 51. Designing an artificial intelligence study in urologic research - p. 261 58. Chapter 52. Patient perspectives - p. 267 59. Part VII. Clinical: Preparation - p. P7 60. Chapter 53. Sample size - p. 275 61. Chapter 54. Budgeting for clinical trials - p. 283 62. Chapter 55. Ethics and review boards - p. 287 63. Chapter 56. Regulatory considerations for new drugs and devices - p. 293 64. Chapter 57. Funding approaches - p. 301 65. Chapter 58. Data management - p. 305 66. Chapter 59. Statistical software - p. 311 67. Chapter 60. Subject adherence - p. 315 68. Chapter 61. Statistical tools for survival analysis in urology - p. 321 69. Chapter 62. Monitoring committees in clinical trials - p. 327 70. Part VIII. Regulatory basics - p. P8 71. Chapter 63. FDA overview - p. 333 72. Chapter 64. Investigational New Drugs - p. 337 73. Chapter 65. New drug application - p. 343 74. Chapter 66. A urologist's primer for the United States FDA approval process for medical devices - p. 349 75. Chapter 67. Biologics - p. 355 76. Chapter 68. Combination products - p. 361 77. Chapter 69. Food and dietary supplements - p. 365 78. Chapter 70. CMC sections of regulatory filings. GxP considerations - p. 369 79. Chapter 71. Postmarket drug safety monitoring - p. 373 80. Chapter 72. Postmarket device safety monitoring - p. 377 81. Part IX. Clinical implementation - p. P9 82. Chapter 73. Implementation of research - p. 383 83. Chapter 74. Design and analysis - p. 389 84. Chapter 75. Population- and setting-specific implementation - p. 393 85. Part X. Public health - p. P10 86. Chapter 76. Public health and translational urology - p. 399 87. Chapter 77. Epidemiology - p. 403 88. Chapter 78. Public health factors and social determinants of health in urological research - p. 407 89. Chapter 79. Forming good research questions - p. 411 90. Chapter 80. Population- and environmental-specific considerations - p. 415 91. Chapter 81. Healthcare systems and institutions as research partners - p. 419 92. Chapter 82. Public health institutions and systems - p. 423 93. Part XI. Practical resources - p. P11 94. Chapter 83. Data presentation for urology research - p. 429 95. Chapter 84. Manuscript preparation: Strategies to optimize your efficiency, productivity, and success - p. 433 96. Chapter 85. Building a team and implementing a urology care initiative - p. 441 97. Chapter 86. Patent basics - p. 445 98. Chapter 87. Basics of starting a company, licensing, partnerships, and acquisition - p. 449 99. Chapter 88. F(u/i)nding your inner entrepreneur via the NIH SBIR STTR mechanisms - p. 459 100. Chapter 89. Sample forms and templates - p. 465
Translational Urology 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 urology, and know what is needed for successful collaboration. Further, this title is an indispensable tool in grant writing and funding efforts.
This 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 urology, 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.
1. Part I. Introduction - p. P1 2. Chapter 1. Introduction - p. 3 3. Chapter 2. Translational process - p. 5 4. Chapter 3. Scientific methods - p. 9 5. Chapter 4. Basic science - p. 13 6. Part II. Pre-clinical - p. P2 7. Chapter 5. Overview of preclinical research - p. 21 8. Chapter 6. Preclinical: What problem are you solving? - p. 25 9. Chapter 7. Types of interventions - p. 31 10. Chapter 8. Drug screening - p. 35 11. Chapter 9. Drug testing - p. 39 12. Chapter 10. Device discovery and prototyping - p. 43 13. Chapter 11. Device testing and regulatory approval - p. 47 14. Chapter 12. Other product types - p. 51 15. Chapter 13. Procedural technique development - p. 55 16. Chapter 14. Behavioral intervention - p. 59 17. Part III. Clinical: Fundamentals - p. P3 18. Chapter 15. Introduction to clinical research: What is it? Why is it needed? - p. 65 19. Chapter 16. Study population: Who and why? - p. 69 20. Chapter 17. Outcome measurements: What data are being collected and why? - p. 73 21. Part IV. Statistical principles - p. P4 22. Chapter 18. Common issues in analysis - p. 81 23. Chapter 19. Basic statistical principles - p. 85 24. Chapter 20. Hypotheses and error types - p. 95 25. Chapter 21. Power - p. 99 26. Chapter 22. Regression - p. 105 27. Chapter 23. Continuous variable analyses: Student's t-test, rank-sum test, and signed-rank test - p. 109 28. Chapter 24. Categorical variable analyses: Chi-square, Fisher exact, and Mantel–Haenszel - p. 115 29. Chapter 25. Analysis of variance - p. 121 30. Chapter 26. Correlation - p. 125 31. Chapter 27. Basic science statistics - p. 131 32. Part V. Clinical: Study types - p. P5 33. Chapter 28. Design principles: Hierarchy of study types - p. 137 34. Chapter 29. Case series: Design, measures, and classic example - p. 141 35. Chapter 30. Case-control study: Design, measures, classic example - p. 145 36. Chapter 31. Cohort study: Design, measures, classic example - p. 149 37. Chapter 32. Cross-sectional study: Design, measures, and classic examples - p. 153 38. Chapter 33. Longitudinal study: Pros and cons, study design, and classic examples - p. 159 39. Chapter 34. Clinical trials: Getting started - p. 165 40. Chapter 35. Meta-analysis: Design, measures, and classic examples - p. 171 41. Chapter 36. Cost-effectiveness analysis: Design, measures, and classic example - p. 177 42. Chapter 37. Database research in urology - p. 185 43. Chapter 38. Surveys and questionnaires - p. 189 44. Chapter 39. Qualitative and mixed methods in urology - p. 195 45. Part VI. Clinical trials - p. P6 46. Chapter 40. Randomized controlled trials: Design, measures, and classic examples - p. 201 47. Chapter 41. Nonrandomized controlled clinical trial - p. 207 48. Chapter 42. Historical control: Design, measures, and classic example - p. 211 49. Chapter 43. Crossover studies - p. 217 50. Chapter 44. Withdrawal studies: Design, measures, and classic examples - p. 221 51. Chapter 45. Equivalence and noninferiority: Design, measures, and classic example - p. 225 52. Chapter 46. Randomization: Fixed or adaptive procedures - p. 229 53. Chapter 47. Blinding: Who and how? - p. 233 54. Chapter 48. Multicenter considerations - p. 245 55. Chapter 49. Phase 0 & window of opportunity clinical trials - p. 249 56. Chapter 50. IDEAL framework for surgical innovation - p. 255 57. Chapter 51. Designing an artificial intelligence study in urologic research - p. 261 58. Chapter 52. Patient perspectives - p. 267 59. Part VII. Clinical: Preparation - p. P7 60. Chapter 53. Sample size - p. 275 61. Chapter 54. Budgeting for clinical trials - p. 283 62. Chapter 55. Ethics and review boards - p. 287 63. Chapter 56. Regulatory considerations for new drugs and devices - p. 293 64. Chapter 57. Funding approaches - p. 301 65. Chapter 58. Data management - p. 305 66. Chapter 59. Statistical software - p. 311 67. Chapter 60. Subject adherence - p. 315 68. Chapter 61. Statistical tools for survival analysis in urology - p. 321 69. Chapter 62. Monitoring committees in clinical trials - p. 327 70. Part VIII. Regulatory basics - p. P8 71. Chapter 63. FDA overview - p. 333 72. Chapter 64. Investigational New Drugs - p. 337 73. Chapter 65. New drug application - p. 343 74. Chapter 66. A urologist's primer for the United States FDA approval process for medical devices - p. 349 75. Chapter 67. Biologics - p. 355 76. Chapter 68. Combination products - p. 361 77. Chapter 69. Food and dietary supplements - p. 365 78. Chapter 70. CMC sections of regulatory filings. GxP considerations - p. 369 79. Chapter 71. Postmarket drug safety monitoring - p. 373 80. Chapter 72. Postmarket device safety monitoring - p. 377 81. Part IX. Clinical implementation - p. P9 82. Chapter 73. Implementation of research - p. 383 83. Chapter 74. Design and analysis - p. 389 84. Chapter 75. Population- and setting-specific implementation - p. 393 85. Part X. Public health - p. P10 86. Chapter 76. Public health and translational urology - p. 399 87. Chapter 77. Epidemiology - p. 403 88. Chapter 78. Public health factors and social determinants of health in urological research - p. 407 89. Chapter 79. Forming good research questions - p. 411 90. Chapter 80. Population- and environmental-specific considerations - p. 415 91. Chapter 81. Healthcare systems and institutions as research partners - p. 419 92. Chapter 82. Public health institutions and systems - p. 423 93. Part XI. Practical resources - p. P11 94. Chapter 83. Data presentation for urology research - p. 429 95. Chapter 84. Manuscript preparation: Strategies to optimize your efficiency, productivity, and success - p. 433 96. Chapter 85. Building a team and implementing a urology care initiative - p. 441 97. Chapter 86. Patent basics - p. 445 98. Chapter 87. Basics of starting a company, licensing, partnerships, and acquisition - p. 449 99. Chapter 88. F(u/i)nding your inner entrepreneur via the NIH SBIR STTR mechanisms - p. 459 100. Chapter 89. Sample forms and templates - p. 465
