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…mehr
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.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Produktdetails
Produktdetails
Handbook for Designing and Conducting Clinical and Translational Research
INTRODUCTION 1. Translational Process 2. Scientific Method 3. Basic research PRE-CLINICAL: DISCOVERY AND DEVELOPMENT 4. Overview of preclinical research 5. Defining the problem to solve 6. Types of problems 7. Types of Interventions 8. Drug discovery 9. Drug safety 10. Device discovery 11. Device prototyping 12. Device classification 13. Device testing 14. Diagnostic testing 15. Other product types 16. Procedural technique development 17. Behavioral intervention CLINICAL: FUNDAMENTALS 18. Introduction to clinical research: What is it? Why is it needed? 19. The question: Types of research questions and how to develop them 20. Study population: Who and why them? 21. Outcome measurements: What data is being collected and why? 22. Optimizing the question: Balancing significance and feasibility STATISTICAL PRINCIPLES 23. Common issues in analysis 24. Basic statistical principles 25. Distributions 26. Hypotheses and error types 27. Power 28. Regression 29. t-test 30. Chi-square 31. Analysis of variance 32. Correlation 33. Biases 34. Basic science statistics CLINICAL: STUDY TYPES 35. Design principles: Hierarchy of study types 36. Case series: Design, measures, classic example 37. Case-control study: Design, measures, classic example 38. Cohort study: Design, measures, classic example 39. Cross-section study: Design, measures, classic example 40. Longitudinal study: Design, measures, classic example 41. Clinical trials: Design, measures, classic example 42. Meta-analysis: Design, measures, classic example 43. Cost-effectiveness analysis: Design, measures, classic example 44. Diagnostic test evaluation: Design, measures, classic example 45. Reliability study: Design, measures, classic example 46. Surveys and questionnaires: Design, measures, classic example 47. Qualitative methods and mixed methods CLINICAL TRIALS 48. Randomized control: Design, measures, classic example 49. Nonrandomized control: Design, measures, classic example 50. Historical control: Design, measures, classic example 51. Cross-over: Design, measures, classic example 52. Withdrawal studies: Design, measures, classic example 53. Factorial design: Design, measures, classic example 54. Group allocation: Design, measures, classic example 55. Large, pragmatic: Design, measures, classic example 56. Equivalence and noninferiority: Design, measures, classic example 57. Adaptive: Design, measures, classic example 58. Randomization: Fixed or adaptive procedures 59. Blinding: Who and how? 60. Multicenter considerations 61. Registries 62. Phases of clinical trials 63. IDEAL Framework 64. Artificial Intelligence 65. Patient perspectives CLINICAL: PREPARATION 66. Meaningful outcome measurements 67. Sample size 68. Budgeting 69. Ethics and review boards 70. Regulatory considerations for new drugs and devices 71. Funding approaches 72. Subject recruitment 73. Data management 74. Quality control 75. Statistical software 76. Report forms: Harm and Quality of Life 77. Subject adherence 78. Monitoring committee in clinical trials REGULATORY 79. FDA overview 80. IND 81. New drug application 82. Device pathways 83. Radiation-emitting electronic products 84. Combination products 85. Cosmetics 86. CMC and GxP 87. Non-US regulatory 88. Post-Market Drug Safety Monitoring 89. Post-Market Device Safety Monitoring CLINICAL IMPLEMENTATION 90. Implementation Research 91. Design and analysis 92. Mixed-methods research 93. Population- and setting-specific implementation PUBLIC HEALTH 94. Public Health 95. Epidemiology 96. Good questions 97. Population- and environmental-specific considerations 98. Law, policy, and ethics 99. Healthcare institutions and systems 100. Public health institutions and systems
INTRODUCTION 1. Translational Process 2. Scientific Method 3. Basic research PRE-CLINICAL: DISCOVERY AND DEVELOPMENT 4. Overview of preclinical research 5. Defining the problem to solve 6. Types of problems 7. Types of Interventions 8. Drug discovery 9. Drug safety 10. Device discovery 11. Device prototyping 12. Device classification 13. Device testing 14. Diagnostic testing 15. Other product types 16. Procedural technique development 17. Behavioral intervention CLINICAL: FUNDAMENTALS 18. Introduction to clinical research: What is it? Why is it needed? 19. The question: Types of research questions and how to develop them 20. Study population: Who and why them? 21. Outcome measurements: What data is being collected and why? 22. Optimizing the question: Balancing significance and feasibility STATISTICAL PRINCIPLES 23. Common issues in analysis 24. Basic statistical principles 25. Distributions 26. Hypotheses and error types 27. Power 28. Regression 29. t-test 30. Chi-square 31. Analysis of variance 32. Correlation 33. Biases 34. Basic science statistics CLINICAL: STUDY TYPES 35. Design principles: Hierarchy of study types 36. Case series: Design, measures, classic example 37. Case-control study: Design, measures, classic example 38. Cohort study: Design, measures, classic example 39. Cross-section study: Design, measures, classic example 40. Longitudinal study: Design, measures, classic example 41. Clinical trials: Design, measures, classic example 42. Meta-analysis: Design, measures, classic example 43. Cost-effectiveness analysis: Design, measures, classic example 44. Diagnostic test evaluation: Design, measures, classic example 45. Reliability study: Design, measures, classic example 46. Surveys and questionnaires: Design, measures, classic example 47. Qualitative methods and mixed methods CLINICAL TRIALS 48. Randomized control: Design, measures, classic example 49. Nonrandomized control: Design, measures, classic example 50. Historical control: Design, measures, classic example 51. Cross-over: Design, measures, classic example 52. Withdrawal studies: Design, measures, classic example 53. Factorial design: Design, measures, classic example 54. Group allocation: Design, measures, classic example 55. Large, pragmatic: Design, measures, classic example 56. Equivalence and noninferiority: Design, measures, classic example 57. Adaptive: Design, measures, classic example 58. Randomization: Fixed or adaptive procedures 59. Blinding: Who and how? 60. Multicenter considerations 61. Registries 62. Phases of clinical trials 63. IDEAL Framework 64. Artificial Intelligence 65. Patient perspectives CLINICAL: PREPARATION 66. Meaningful outcome measurements 67. Sample size 68. Budgeting 69. Ethics and review boards 70. Regulatory considerations for new drugs and devices 71. Funding approaches 72. Subject recruitment 73. Data management 74. Quality control 75. Statistical software 76. Report forms: Harm and Quality of Life 77. Subject adherence 78. Monitoring committee in clinical trials REGULATORY 79. FDA overview 80. IND 81. New drug application 82. Device pathways 83. Radiation-emitting electronic products 84. Combination products 85. Cosmetics 86. CMC and GxP 87. Non-US regulatory 88. Post-Market Drug Safety Monitoring 89. Post-Market Device Safety Monitoring CLINICAL IMPLEMENTATION 90. Implementation Research 91. Design and analysis 92. Mixed-methods research 93. Population- and setting-specific implementation PUBLIC HEALTH 94. Public Health 95. Epidemiology 96. Good questions 97. Population- and environmental-specific considerations 98. Law, policy, and ethics 99. Healthcare institutions and systems 100. Public health institutions and systems
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