Translational Interventional Radiology, a volume in the Handbook for Designing and Conducting Clinical and Translational Research series, covers the principles of evidence-based medicine and applies these principles to the design of translational investigations in Interventional Radiology. 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 Interventional Radiology, and know what is needed for successful collaboration. Further, this reference is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps aspiring investigators navigate challenging considerations in study design and implementation. This book provides valuable discussions of the critical appraisal of published studies in Interventional Radiology, elucidating the evaluation of the quality with respect to measuring outcomes and making effective use of all types of evidence in patient care. In short, this practical guide will be of interest to every medical researcher and interventional radiologist who has ever had a good clinical idea but not the knowledge of how to test it.
1. Chapter 18 Introduction to clinical research - p. 95 2. Chapter 19 The question - p. 99 3. Chapter 20 Study population - p. 101 4. Chapter 21 Outcome measurements - p. 105 5. Chapter 22 Optimizing the question - p. 109 6. Chapter 23 Common issues in analysis - p. 117 7. Chapter 24 Everyday statistics for the clinician - p. 119 8. Chapter 25 Distributions - p. 123 9. Chapter 26 Hypotheses and types of error - p. 127 10. Chapter 27 Power - p. 129 11. Chapter 28 Regression analysis - p. 133 12. Chapter 29 t-test - p. 139 13. Chapter 30 Chi square - p. 145 14. Chapter 31 Analysis of variance - p. 149 15. Chapter 32 Correlation - p. 153 16. Chapter 33 Biases - p. 157 17. Chapter 34 Basic science statistics - p. 163 18. Chapter 35 Design principles - p. 171 19. Chapter 36 Case series - p. 177 20. Chapter 37 Case-control study - p. 181 21. Chapter 38 Cohort study - p. 185 22. Chapter 39 Cross-sectional study - p. 189 23. Chapter 40 Longitudinal study - p. 195 24. Chapter 41 Clinical trials - p. 203 25. Chapter 42 Meta-analysis - p. 209 26. Chapter 43 Cost-effectiveness analysis - p. 215 27. Chapter 44 Diagnostic test evaluation - p. 221 28. Chapter 45 Reliability study - p. 225 29. Chapter 46 Surveys and questionnaires - p. 229 30. Chapter 47 Qualitative methods and mixed methods - p. 233 31. Chapter 48 Randomized control - p. 237 32. Chapter 49 Nonrandomized controlled trials - p. 241 33. Chapter 50 Historical control - p. 245 34. Chapter 51 Cross-over - p. 249 35. Chapter 52 The withdrawal design - p. 253 36. Chapter 53 Factorial design - p. 257 37. Chapter 54 Group allocation - p. 263 38. Chapter 55 Large, pragmatic - p. 267 39. Chapter 56 Equivalence and noninferiority - p. 273 40. Chapter 57 Adaptive - p. 279 41. Chapter 58 Randomization - p. 281 42. Chapter 59 Blinding - p. 285 43. Chapter 60 Multicenter considerations - p. 293 44. Chapter 61 Registries - p. 297 45. Chapter 62 Phases of clinical trials - p. 303 46. Chapter 63 The IDEAL framework - p. 309 47. Chapter 64 Studies to assess AI methodology in clinical research - p. 315 48. Chapter 65 Patient perspectives - p. 321 49. Chapter 66 Meaningful outcome measurements - p. 327 50. Chapter 67 Sample size - p. 333 51. Chapter 68 Budgeting - p. 337 52. Chapter 69 Ethics and review boards - p. 341 53. Chapter 70 Regulatory considerations for drugs and devices seeking FDA approval or off-label uses - p. 345 54. Chapter 71 Funding approaches - p. 351 55. Chapter 72 Subject recruitment - p. 355 56. Chapter 73 Data management - p. 359 57. Chapter 74 Quality control in IR translational research - p. 363 58. Chapter 75 Statistical software - p. 367 59. Chapter 76 Report forms - p. 373 60. Chapter 77 Subject adherence - p. 379 61. Chapter 78 Monitoring committee in clinical trials - p. 383 62. Chapter 79 The FDA - p. 389 63. Chapter 80 Investigational new drugs - p. 395 64. Chapter 81 New drug application process - p. 401 65. Chapter 82 Medical device pathways - p. 405 66. Chapter 83 Radiation-emitting electronic products - p. 411 67. Chapter 84 Combination products - p. 415 68. Chapter 85 Cosmetics - p. 421 69. Chapter 86 CMC and GxP - p. 425 70. Chapter 87 Non-US regulatory - p. 431 71. Chapter 88 Postmarketing drug safety monitoring - p. 435 72. Chapter 89 Postmarket device safety monitoring - p. 439 73. Chapter 90 Implementation research in interventional radiology - p. 445 74. Chapter 91 Implementation research: Design and analysis - p. 451 75. Chapter 92 Mixed methods research - p. 459 76. Chapter 93 Population- and setting-specific implementations - p. 463 77. Chapter 94 Public health research - p. 471 78. Chapter 95 Epidemiology - p. 475 79. Chapter 96 Good questions - p. 481 80. Chapter 97 Translational interventional radiology - p. 487 81. Chapter 98 Ethics, policy, and law - p. 489 82. Chapter 99 Healthcare institutions and systems - p. 493 83. Chapter 100 Public health institutions and systems - p. 497 84. Chapter 101 Presenting data - p. 503 85. Chapter 102 Manuscript preparation - p. 507 86. Chapter 103 Research team: Standard personnel and roles - p. 515 87. Chapter 104 Patent basics - p. 519 88. Chapter 105 Venture pathways - p. 523 89. Chapter 106 Small business innovation research/small business technology transfer (SBIR/STTR) - p. 529 90. Chapter 107 Sample forms and templates - p. 533 91. Glossary terms - p. 557 92. Index - p. 571
Translational Interventional Radiology, a volume in the Handbook for Designing and Conducting Clinical and Translational Research series, covers the principles of evidence-based medicine and applies these principles to the design of translational investigations in Interventional Radiology. 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 Interventional Radiology, and know what is needed for successful collaboration. Further, this reference is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps aspiring investigators navigate challenging considerations in study design and implementation. This book provides valuable discussions of the critical appraisal of published studies in Interventional Radiology, elucidating the evaluation of the quality with respect to measuring outcomes and making effective use of all types of evidence in patient care. In short, this practical guide will be of interest to every medical researcher and interventional radiologist who has ever had a good clinical idea but not the knowledge of how to test it.
1. Chapter 18 Introduction to clinical research - p. 95 2. Chapter 19 The question - p. 99 3. Chapter 20 Study population - p. 101 4. Chapter 21 Outcome measurements - p. 105 5. Chapter 22 Optimizing the question - p. 109 6. Chapter 23 Common issues in analysis - p. 117 7. Chapter 24 Everyday statistics for the clinician - p. 119 8. Chapter 25 Distributions - p. 123 9. Chapter 26 Hypotheses and types of error - p. 127 10. Chapter 27 Power - p. 129 11. Chapter 28 Regression analysis - p. 133 12. Chapter 29 t-test - p. 139 13. Chapter 30 Chi square - p. 145 14. Chapter 31 Analysis of variance - p. 149 15. Chapter 32 Correlation - p. 153 16. Chapter 33 Biases - p. 157 17. Chapter 34 Basic science statistics - p. 163 18. Chapter 35 Design principles - p. 171 19. Chapter 36 Case series - p. 177 20. Chapter 37 Case-control study - p. 181 21. Chapter 38 Cohort study - p. 185 22. Chapter 39 Cross-sectional study - p. 189 23. Chapter 40 Longitudinal study - p. 195 24. Chapter 41 Clinical trials - p. 203 25. Chapter 42 Meta-analysis - p. 209 26. Chapter 43 Cost-effectiveness analysis - p. 215 27. Chapter 44 Diagnostic test evaluation - p. 221 28. Chapter 45 Reliability study - p. 225 29. Chapter 46 Surveys and questionnaires - p. 229 30. Chapter 47 Qualitative methods and mixed methods - p. 233 31. Chapter 48 Randomized control - p. 237 32. Chapter 49 Nonrandomized controlled trials - p. 241 33. Chapter 50 Historical control - p. 245 34. Chapter 51 Cross-over - p. 249 35. Chapter 52 The withdrawal design - p. 253 36. Chapter 53 Factorial design - p. 257 37. Chapter 54 Group allocation - p. 263 38. Chapter 55 Large, pragmatic - p. 267 39. Chapter 56 Equivalence and noninferiority - p. 273 40. Chapter 57 Adaptive - p. 279 41. Chapter 58 Randomization - p. 281 42. Chapter 59 Blinding - p. 285 43. Chapter 60 Multicenter considerations - p. 293 44. Chapter 61 Registries - p. 297 45. Chapter 62 Phases of clinical trials - p. 303 46. Chapter 63 The IDEAL framework - p. 309 47. Chapter 64 Studies to assess AI methodology in clinical research - p. 315 48. Chapter 65 Patient perspectives - p. 321 49. Chapter 66 Meaningful outcome measurements - p. 327 50. Chapter 67 Sample size - p. 333 51. Chapter 68 Budgeting - p. 337 52. Chapter 69 Ethics and review boards - p. 341 53. Chapter 70 Regulatory considerations for drugs and devices seeking FDA approval or off-label uses - p. 345 54. Chapter 71 Funding approaches - p. 351 55. Chapter 72 Subject recruitment - p. 355 56. Chapter 73 Data management - p. 359 57. Chapter 74 Quality control in IR translational research - p. 363 58. Chapter 75 Statistical software - p. 367 59. Chapter 76 Report forms - p. 373 60. Chapter 77 Subject adherence - p. 379 61. Chapter 78 Monitoring committee in clinical trials - p. 383 62. Chapter 79 The FDA - p. 389 63. Chapter 80 Investigational new drugs - p. 395 64. Chapter 81 New drug application process - p. 401 65. Chapter 82 Medical device pathways - p. 405 66. Chapter 83 Radiation-emitting electronic products - p. 411 67. Chapter 84 Combination products - p. 415 68. Chapter 85 Cosmetics - p. 421 69. Chapter 86 CMC and GxP - p. 425 70. Chapter 87 Non-US regulatory - p. 431 71. Chapter 88 Postmarketing drug safety monitoring - p. 435 72. Chapter 89 Postmarket device safety monitoring - p. 439 73. Chapter 90 Implementation research in interventional radiology - p. 445 74. Chapter 91 Implementation research: Design and analysis - p. 451 75. Chapter 92 Mixed methods research - p. 459 76. Chapter 93 Population- and setting-specific implementations - p. 463 77. Chapter 94 Public health research - p. 471 78. Chapter 95 Epidemiology - p. 475 79. Chapter 96 Good questions - p. 481 80. Chapter 97 Translational interventional radiology - p. 487 81. Chapter 98 Ethics, policy, and law - p. 489 82. Chapter 99 Healthcare institutions and systems - p. 493 83. Chapter 100 Public health institutions and systems - p. 497 84. Chapter 101 Presenting data - p. 503 85. Chapter 102 Manuscript preparation - p. 507 86. Chapter 103 Research team: Standard personnel and roles - p. 515 87. Chapter 104 Patent basics - p. 519 88. Chapter 105 Venture pathways - p. 523 89. Chapter 106 Small business innovation research/small business technology transfer (SBIR/STTR) - p. 529 90. Chapter 107 Sample forms and templates - p. 533 91. Glossary terms - p. 557 92. Index - p. 571
