Translational Orthopedics: Designing and Conducting Translational Research 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 translational orthopedics, 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 translational orthopedics, 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 Orthopedist who has ever had a good clinical idea but not the knowledge of how to test it.
- Focuses on the principles of evidence-based medicine and applies these principles to the design of translational investigations within orthopedics
- Provides a practical, straightforward approach that helps investigators navigate challenging considerations in study design and implementation
- Details discussions of the critical appraisal of published studies in translational orthopedics, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care
Sprache
Verlagsort
Verlagsgruppe
Elsevier Science & Techn.
Dateigröße
ISBN-13
978-0-323-88562-1 (9780323885621)
Schweitzer Klassifikation
PrefaceAdam E. M. EltoraiIntroduction1. Introduction2. Translational Process3. Scientific Method4. Basic researchPRE-CLINCIAL5. Overview of Preclinical Research6. What Problem are you Solving?7. Types of Interventions8. Drug discovery9. Drug Testing10. Device discovery and prototyping11. Device testing12. Diagnostic Discovery13. Diagnostic Testing14. Other Product Types15. Procedural Technique Development16. Behavioral InterventionCLINICAL: FUNDAMENTALS17. Introduction to clinical research18. The question19. Study population20. Outcome measurements21. Optimizing the questionSTATISTICAL PRINCIPLES22. Common issues in analysis23. Basic statistical principles24. Distributions25. Hypotheses and error types26. Power27. Regression28. Continuous variable analyses29. Categorical variable analyses30. Analysis of variance31. Correlation32. Biases33. Basic science statisticsCLINICAL: STUDY TYPES34. Design principles35. Case series36. Case-control study37. Cohort study38. Cross-section study39. Longitudinal Study40. Clinical trials41. Meta-analysis42. Cost effectiveness study43. Diagnostic test evaluation44. Reliability study45. Database studies46. Surveys and questionnaires47. Qualitative methods and mixed methodsCLINICAL TRIALS48. Randomized control49. Nonrandomized control50. Historical control51. Cross-over52. Withdrawal studies53. Factorial design54. Group allocation55. Hybrid design56. Large, pragmatic57. Adaptive58. Randomization59. Blinding60. Multicenter considerations61. Registries62. Phases of Clinical Trials63. IDEAL Framework64. Artificial Intelligence65. Patient PerspectivesCLINICAL: PREPARATION66. Sample size67. Budgeting 68. Ethics and review boards69. Regulatory considerations for new drugs and devices70. Funding approaches71. Subject recruitment72. Data management74. Statistical Software75. Report forms76. Subject adherence77. Survival analysis78. Monitoring committee in clinical trialsREGULATORY BASICS79. FDA Overview80. IND81. New drug application82. Devices83. Radiation-emitting Electronic Products84. Orphan Drugs85. Biologics86. Combination Productions87. Foods88. Cosmetics89. CMC and GxP90. Non-US regulatory91. Post-market drug safety monitoring92. Post-market device safety monitoringCLINICAL IMPLEMENTATION93. Implementation Research94. Design and Analysis95. Mixed Methods Research96. Population- and setting-specific implementationPUBLIC HEALTH97. Public Health98. Epidemiology99. Factors100. Good questions101. Population- and environmental-specific considerations102. Law, policy, and ethics103. Healthcare institutions and systems104. Public health institutions and systemsPractical Resources105. Presenting data106. Manuscript preparation107. Building a team108. Patent basics109. Venture pathways110. SBIR/STTR111. Sample forms and templates
