Translational Gastroenterology covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. Readers will learn important concepts, including case-control study, prospective cohort study, randomized trials, and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in gastroenterology, 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 gastroenterology, 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 gastroenterologist who has ever had a good clinical idea but not the knowledge of how to test it.
1. Part I. Introduction - p. 1 2. Chapter 1. Introduction - p. 3 3. Chapter 2. Translational process - p. 5 4. Chapter 3. Scientific method - p. 9 5. Chapter 4. Basic research and translational research interplay in clinical field - p. 15 6. Part II. Pre-clinical - p. 19 7. Chapter 5. Overview of preclinical research - p. 21 8. Chapter 6. What problem are you solving? - p. 29 9. Chapter 7. Type of interventions for problems - p. 33 10. Chapter 8. Drug discovery: Disciplines and common lab methods - p. 37 11. Chapter 9. Drug testing - p. 41 12. Chapter 10. Device discovery and prototyping - p. 45 13. Chapter 11. Device testing - p. 49 14. Chapter 12. Diagnostic discovery - p. 57 15. Chapter 13. Diagnostic testing - p. 65 16. Chapter 14. Procedural technique development - p. 75 17. Chapter15. Behavioral interventions for gastrointestinal disorders - p. 81 18. Part III. Clinical: Fundamentals - p. 85 19. Chapter 16. Introduction to clinical research: What is it? Why is it needed? - p. 87 20. Chapter 17. The question: Types of research questions and how to develop them - p. 91 21. Chapter 18. Study population: Who and why them? - p. 95 22. Chapter 19. Outcome measurements - p. 99 23. Chapter 20. Significance and feasibility of studies - p. 103 24. Part IV. Statistical principles - p. 107 25. Chapter 21. Common issues in analysis - p. 109 26. Chapter 22. Basic statistical principles - p. 115 27. Chapter 23. Distributions - p. 119 28. Chapter 24. Hypothesis and error types in studies - p. 123 29. Chapter 25. Power of studies - p. 127 30. Chapter 26. Regression - p. 131 31. Chapter 27. Continuous variable analyses: T-test, Mann–Whitney test, and Wilcoxon signed-rank test - p. 135 32. Chapter 28. Categorical variable analyses: Chi-squared, Fisher’s exact, and Mantel–Haenszel - p. 137 33. Chapter 29. Analysis of variance (ANOVA) - p. 139 34. Chapter 30. Correlation - p. 145 35. Chapter 31. Bias - p. 149 36. Chapter 32. Basic science statistics - p. 151 37. Part V. Clinical: Study types - p. 157 38. Chapter 33. Design principles: Hierarchy of study types - p. 159 39. Chapter 34. Case series: Design, measures, and classic example - p. 163 40. Chapter 35. Case-control study: design, measures, and classic example - p. 165 41. Chapter 36. Basic principles of cohort studies and practical application in gastroenterological literature - p. 169 42. Chapter 37. Cross-sectional studies: Design, measures, classic example - p. 175 43. Chapter 38. Longitudinal studies: Design, measures, and classic example - p. 179 44. Chapter 39. Clinical trials: Design, measures, classic example - p. 183 45. Chapter 40. Meta-analysis - p. 187 46. Chapter 41. Cost-effectiveness study: Design, measures, and classic example - p. 193 47. Chapter 42. Diagnostic test evaluation: Design, measures, and classic examples - p. 195 48. Chapter 43. Reliability study: Design, measures, classic examples - p. 199 49. Chapter 44. Database studies: design, measures, and classic examples - p. 201 50. Chapter 45. Surveys and questionnaires - p. 209 51. Chapter 46. Qualitative methods and mixed methods - p. 213 52. Part VI. Clinical trials - p. 217 53. Chapter 47. Randomized controlled trial - p. 219 54. Chapter 48. Nonrandomized control: Design, measures, classic example - p. 225 55. Chapter 49. Historical control: Design, measures, classic example - p. 229 56. Chapter 50. Crossover: Design, measures, and classic example - p. 235 57. Chapter 51. Withdrawal studies: Design, measures, and classic examples in gastrointestinal research - p. 241 58. Chapter 52. Factorial study design - p. 245 59. Chapter 53. Group allocation: Design, measures, classic examples - p. 251 60. Chapter 54. Hybrid clinical trial design: Design, measures, classic examples - p. 255 61. Chapter 55. Large pragmatic research: Design, measures, classic example - p. 261 62. Chapter 56. Equivalence and noninferiority testing - p. 265 63. Chapter 57. Adaptive study design - p. 269 64. Chapter 58. Randomization: Fixed or adaptive procedures - p. 273 65. Chapter 59. Blinding: Who and how? - p. 277 66. Chapter 60. Multicenter considerations - p. 283 67. Chapter 61. Registries - p. 287 68. Chapter 62. Phases of clinical trials - p. 291 69. Chapter 63. IDEAL framework for describing the stages of innovation in surgery - p. 297 70. Chapter 64. Applications of artificial intelligence in gastroenterology - p. 301 71. Chapter 65. Patient perspectives in clinical research - p. 307 72. Part VII. Clinical: Preparation - p. 313 73. Chapter 66. Choosing the right sample size - p. 315 74. Chapter 67. NIH budgeting - p. 317 75. Chapter 68. Ethics and review boards - p. 321 76. Chapter 69. Funding approaches: Federal and private funding agencies - p. 327 77. Chapter 70. Subject recruitment - p. 331 78. Chapter 71. Data management - p. 335 79. Chapter 72. Quality control - p. 339 80. Chapter 73. Statistical software - p. 343 81. Chapter 74. Report forms—Harm and quality of life - p. 355 82. Chapter 75. Subject adherence - p. 359 83. Chapter 76. Survival analysis - p. 363 84. Chapter 77. Monitoring committee in clinical trials - p. 367 85. Part VIII. Regulatory basics - p. 371 86. Chapter 78. Orphan drugs - p. 373 87. Chapter 79. Biologics - p. 377 88. Chapter 80. Foods - p. 379 89. Chapter 81. Cosmetics and cosmeceuticals - p. 383 90. Chapter 82. FDA overview and guidelines with gastrointestinal product examples - p. 387 91. Chapter 83. Non-US regulatory - p. 393 92. Chapter 84. Postmarket drug safety monitoring - p. 395 93. Chapter 85. Postmarket device safety monitoring - p. 399 94. Part IX. Clinical implementation - p. 403 95. Chapter 86. Implementation research - p. 405 96. Chapter 87. Design and analysis of target trials - p. 409 97. Chapter 88. Population and setting specific implementation - p. 413 98. Part X. Public health - p. 417 99. Chapter 89. Public health research - p. 419 100. Chapter 90. Epidemiology and translational research - p. 423 101. Chapter 91. Factors impacting individual health and public health outcomes - p. 427 102. Chapter 92. Public health: Good questions - p. 435 103. Chapter 93. Population and environment-specific considerations - p. 437 104. Chapter 94. Law, policy, and ethics - p. 441 105. Chapter 95. Healthcare institutions and systems - p. 445 106. Chapter 96. Public health institutions and systems - p. 449 107. Part XI. Practical resources - p. 453 108. Chapter 97. Presenting data - p. 455 109. Chapter 98. Manuscript preparation - p. 459 110. Chapter 99. Building a team - p. 465 111. Chapter 100. Patent basics - p. 471 112. Chapter 101. Venture capital - p. 473 113. Chapter 102. Small business innovation research and small business technology transfer NIH grants - p. 479 114. Chapter 103. Research performance guidelines - p. 483 115. Glossary - p. 487 116. Index - p. 495
Translational Gastroenterology covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. Readers will learn important concepts, including case-control study, prospective cohort study, randomized trials, and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in gastroenterology, 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 gastroenterology, 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 gastroenterologist who has ever had a good clinical idea but not the knowledge of how to test it.
1. Part I. Introduction - p. 1 2. Chapter 1. Introduction - p. 3 3. Chapter 2. Translational process - p. 5 4. Chapter 3. Scientific method - p. 9 5. Chapter 4. Basic research and translational research interplay in clinical field - p. 15 6. Part II. Pre-clinical - p. 19 7. Chapter 5. Overview of preclinical research - p. 21 8. Chapter 6. What problem are you solving? - p. 29 9. Chapter 7. Type of interventions for problems - p. 33 10. Chapter 8. Drug discovery: Disciplines and common lab methods - p. 37 11. Chapter 9. Drug testing - p. 41 12. Chapter 10. Device discovery and prototyping - p. 45 13. Chapter 11. Device testing - p. 49 14. Chapter 12. Diagnostic discovery - p. 57 15. Chapter 13. Diagnostic testing - p. 65 16. Chapter 14. Procedural technique development - p. 75 17. Chapter15. Behavioral interventions for gastrointestinal disorders - p. 81 18. Part III. Clinical: Fundamentals - p. 85 19. Chapter 16. Introduction to clinical research: What is it? Why is it needed? - p. 87 20. Chapter 17. The question: Types of research questions and how to develop them - p. 91 21. Chapter 18. Study population: Who and why them? - p. 95 22. Chapter 19. Outcome measurements - p. 99 23. Chapter 20. Significance and feasibility of studies - p. 103 24. Part IV. Statistical principles - p. 107 25. Chapter 21. Common issues in analysis - p. 109 26. Chapter 22. Basic statistical principles - p. 115 27. Chapter 23. Distributions - p. 119 28. Chapter 24. Hypothesis and error types in studies - p. 123 29. Chapter 25. Power of studies - p. 127 30. Chapter 26. Regression - p. 131 31. Chapter 27. Continuous variable analyses: T-test, Mann–Whitney test, and Wilcoxon signed-rank test - p. 135 32. Chapter 28. Categorical variable analyses: Chi-squared, Fisher’s exact, and Mantel–Haenszel - p. 137 33. Chapter 29. Analysis of variance (ANOVA) - p. 139 34. Chapter 30. Correlation - p. 145 35. Chapter 31. Bias - p. 149 36. Chapter 32. Basic science statistics - p. 151 37. Part V. Clinical: Study types - p. 157 38. Chapter 33. Design principles: Hierarchy of study types - p. 159 39. Chapter 34. Case series: Design, measures, and classic example - p. 163 40. Chapter 35. Case-control study: design, measures, and classic example - p. 165 41. Chapter 36. Basic principles of cohort studies and practical application in gastroenterological literature - p. 169 42. Chapter 37. Cross-sectional studies: Design, measures, classic example - p. 175 43. Chapter 38. Longitudinal studies: Design, measures, and classic example - p. 179 44. Chapter 39. Clinical trials: Design, measures, classic example - p. 183 45. Chapter 40. Meta-analysis - p. 187 46. Chapter 41. Cost-effectiveness study: Design, measures, and classic example - p. 193 47. Chapter 42. Diagnostic test evaluation: Design, measures, and classic examples - p. 195 48. Chapter 43. Reliability study: Design, measures, classic examples - p. 199 49. Chapter 44. Database studies: design, measures, and classic examples - p. 201 50. Chapter 45. Surveys and questionnaires - p. 209 51. Chapter 46. Qualitative methods and mixed methods - p. 213 52. Part VI. Clinical trials - p. 217 53. Chapter 47. Randomized controlled trial - p. 219 54. Chapter 48. Nonrandomized control: Design, measures, classic example - p. 225 55. Chapter 49. Historical control: Design, measures, classic example - p. 229 56. Chapter 50. Crossover: Design, measures, and classic example - p. 235 57. Chapter 51. Withdrawal studies: Design, measures, and classic examples in gastrointestinal research - p. 241 58. Chapter 52. Factorial study design - p. 245 59. Chapter 53. Group allocation: Design, measures, classic examples - p. 251 60. Chapter 54. Hybrid clinical trial design: Design, measures, classic examples - p. 255 61. Chapter 55. Large pragmatic research: Design, measures, classic example - p. 261 62. Chapter 56. Equivalence and noninferiority testing - p. 265 63. Chapter 57. Adaptive study design - p. 269 64. Chapter 58. Randomization: Fixed or adaptive procedures - p. 273 65. Chapter 59. Blinding: Who and how? - p. 277 66. Chapter 60. Multicenter considerations - p. 283 67. Chapter 61. Registries - p. 287 68. Chapter 62. Phases of clinical trials - p. 291 69. Chapter 63. IDEAL framework for describing the stages of innovation in surgery - p. 297 70. Chapter 64. Applications of artificial intelligence in gastroenterology - p. 301 71. Chapter 65. Patient perspectives in clinical research - p. 307 72. Part VII. Clinical: Preparation - p. 313 73. Chapter 66. Choosing the right sample size - p. 315 74. Chapter 67. NIH budgeting - p. 317 75. Chapter 68. Ethics and review boards - p. 321 76. Chapter 69. Funding approaches: Federal and private funding agencies - p. 327 77. Chapter 70. Subject recruitment - p. 331 78. Chapter 71. Data management - p. 335 79. Chapter 72. Quality control - p. 339 80. Chapter 73. Statistical software - p. 343 81. Chapter 74. Report forms—Harm and quality of life - p. 355 82. Chapter 75. Subject adherence - p. 359 83. Chapter 76. Survival analysis - p. 363 84. Chapter 77. Monitoring committee in clinical trials - p. 367 85. Part VIII. Regulatory basics - p. 371 86. Chapter 78. Orphan drugs - p. 373 87. Chapter 79. Biologics - p. 377 88. Chapter 80. Foods - p. 379 89. Chapter 81. Cosmetics and cosmeceuticals - p. 383 90. Chapter 82. FDA overview and guidelines with gastrointestinal product examples - p. 387 91. Chapter 83. Non-US regulatory - p. 393 92. Chapter 84. Postmarket drug safety monitoring - p. 395 93. Chapter 85. Postmarket device safety monitoring - p. 399 94. Part IX. Clinical implementation - p. 403 95. Chapter 86. Implementation research - p. 405 96. Chapter 87. Design and analysis of target trials - p. 409 97. Chapter 88. Population and setting specific implementation - p. 413 98. Part X. Public health - p. 417 99. Chapter 89. Public health research - p. 419 100. Chapter 90. Epidemiology and translational research - p. 423 101. Chapter 91. Factors impacting individual health and public health outcomes - p. 427 102. Chapter 92. Public health: Good questions - p. 435 103. Chapter 93. Population and environment-specific considerations - p. 437 104. Chapter 94. Law, policy, and ethics - p. 441 105. Chapter 95. Healthcare institutions and systems - p. 445 106. Chapter 96. Public health institutions and systems - p. 449 107. Part XI. Practical resources - p. 453 108. Chapter 97. Presenting data - p. 455 109. Chapter 98. Manuscript preparation - p. 459 110. Chapter 99. Building a team - p. 465 111. Chapter 100. Patent basics - p. 471 112. Chapter 101. Venture capital - p. 473 113. Chapter 102. Small business innovation research and small business technology transfer NIH grants - p. 479 114. Chapter 103. Research performance guidelines - p. 483 115. Glossary - p. 487 116. Index - p. 495
