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Translational Geriatrics
- 1st Edition - June 1, 2099
- Editors: Jeffrey A. Bakal, Brian Mikolasko, Adam E.M. Eltorai
- Language: English
- eBook ISBN:9 7 8 - 0 - 3 2 3 - 9 1 8 4 5 - 9
Translational Geriatrics covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fu… Read more
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Request a sales quoteTranslational Geriatrics 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 geriatric medicine, and know what is needed for successful 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 geriatrics, 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 and Geriatrician who has ever had a good clinical idea but not the knowledge of how to test it.
- Focusing on translational geriatric research, this volume covers the principles of evidence-based medicine and applies these principles to the design of translational investigations.
- 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 urology, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care.
Geriatricians, geriatric researchers, basic scientists interested in translating their research into clinical practice
Foreword
INTRODUCTION
1. Introduction
2. Translational Process
3. Scientific Method
4. Basic research
PRE-CLINCIAL
5. Overview of preclinical research
6. What problem are you solving?
7. Types of interventions
8. Drug discovery
9. Drug testing
10. Device discovery and prototyping
11. Device testing
12. Diagnostic discovery
13. Diagnostic testing
14. Other product types
15. Procedural technique development
16. Behavioral intervention
CLINICAL: FUNDAMENTALS
17. Introduction to clinical research: What is it? Why is it needed?
18. The question: Types of research questions and how to develop them
19. Study population: Who and why them?
20. Outcome measurements: What data is being collected and why?
21. Optimizing the question: Balancing significance and feasibility added chapter per reviewer suggestion
STATISTICAL PRINCIPLES
22. Common issues in analysis
23. Basic statistical principles
24. Distributions
25. Hypotheses and error types
26. Power
27. Regression
28. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank
29. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel
30. Analysis of variance
31. Correlation
32. Biases
33. Basic science statistics
CLINICAL: STUDY TYPES
34. Design principles: Hierarchy of study types
35. Case series: Design, measures, classic example
36. Case-control study: Design, measures, classic example
37. Cohort study: Design, measures, classic example
38. Cross-section study: Design, measures, classic example
39. Longitudinal study: Design, measures, classic example
40. Clinical trials: Design, measures, classic example
41. Meta-analysis: Design, measures, classic example
42. Cost-effectiveness study: Design, measures, classic example
43. Diagnostic test evaluation: Design, measures, classic example
44. Reliability study: Design, measures, classic example
45. Database studies: 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. Hybrid design: Design, measures, classic example
56. Large, pragmatic: Design, measures, classic example
57. Equivalence and noninferiority: Design, measures, classic example
58. Adaptive: Design, measures, classic example
59. Randomization: Fixed or adaptive procedures
60. Blinding: Who and how?
61. Multicenter considerations
62. Registries
63. Phases of clinical trials added chapter per reviewer suggestion
64. IDEAL Framework
65. Artificial Intelligence
66. Patient perspectives added chapter per reviewer suggestion
CLINICAL: PREPARATION
67. Sample size
68. Budgeting
69. Ethics and review boards
70. Regulatory considerations for new drugs and devices
71. Funding approaches
72. Conflicts of interest added chapter per reviewer suggestion
73. Subject recruitment
74. Data management
75. Quality control
76. Research in acute settings added chapter per reviewer suggestion
77. Special populations added chapter per reviewer suggestion
78. Statistical software added chapter per reviewer suggestion
79. Report forms: Harm and Quality of Life
80. Subject adherence
81. Survival analysis
82. Monitoring committee in clinical trials
REGULATORY BASICS
83. FDA overview
84. IND added chapter per reviewer suggestion
85. New drug application
86. Devices
87. Radiation-emitting electronic products added chapter per reviewer suggestion
88. Orphan drugs added chapter per reviewer suggestion
89. Biologics added chapter per reviewer suggestion
90. Combination products added chapter per reviewer suggestion
91. Foods added chapter per reviewer suggestion
92. Cosmetics added chapter per reviewer suggestion
93. CMC and GxP
94. Non-US regulatory
95. Post-Market Drug Safety Monitoring
96. Post-Market Device Safety Monitoring
CLINICAL IMPLEMENTATION
97. Implementation Research
98. Design and analysis
99. Mixed-methods research
100. Population- and setting-specific implementation
101. Guideline development added chapter per reviewer suggestion
PUBLIC HEALTH
102. Public Health
103. Epidemiology
104. Factors
105. Good questions
106. Population- and environmental-specific considerations
107. Law, policy, and ethics
108. Healthcare institutions and systems
109. Public health institutions and systems
APPENDIX
110. Presenting data
111. Manuscript preparation added chapter per reviewer suggestion
112. Promoting research added chapter per reviewer suggestion
113. Quality improvement added chapter per reviewer suggestion
114. Harmonizing measures added chapter per reviewer suggestion
115. Team science and building a team added chapter per reviewer suggestion
116. Patent basics
117. Venture pathways
118. SBIR/STTR added chapter per reviewer suggestion
119. Sample forms and templates
Resources
Glossary
References
Index
- No. of pages: 830
- Language: English
- Edition: 1
- Published: June 1, 2099
- Imprint: Academic Press
- eBook ISBN: 9780323918459
JB
Jeffrey A. Bakal
Jeff Bakal PhD, P.Stat. is the Program Director for Provincial Research Data Services at Alberta Health Services which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform and Health Service Statistical & Analytics Methods teams. He has over 10 years of experience working with Health Services data and Randomized Clinical Trials. He completed his PhD jointly with the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen's University. He has worked on the methodology and analysis of several international studies in business strategy, ophthalmology, cardiology, geriatric medicine and the analysis of kinematic data resulting in several peer reviewed articles and conference presentations. His current interests are in developing statistical methodology for time-to-event data and the development of classification tools to assist in patient decision making processes.
Affiliations and expertise
Program Director, Provincial Research Data Services, Data Integration Management and Reporting of Alberta Health Services, Edmonton, Alberta, CanadaBM
Brian Mikolasko
Brian Mikolasko, MD, is a geriatrician on faculty at Brown University. He completed his medical school at Wake Forest, his residency at NYMC, and fellowships in Geriatrics, Hospice, Palliative Care at Mount Sinai. His clinical interests include exploring areas of medicine that palliative care can better serve, developing educational models to expand primary palliative care, developing collaborations to expand how palliative care is provided. His research is focused on clinical and translational geriatrics.
Affiliations and expertise
Brown University, USAAE
Adam E.M. Eltorai
Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.
Affiliations and expertise
Harvard Medical School, Boston, MA, USA