Long description:

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.

• Provides a clear process for understanding, designing, executing, and analyzing translational and clinical research
• Presents practical and step-by-step guidance to help readers take ideas from the lab to the bedside
• Written by a team of experts who cover the breadth of translational research in Gastroenterology

Table of Contents:

PART I: CONCEPT
1. Introduction to clinical research
2. The question
3. Study population
4. Outcome measurements

PART II: STUDY TYPES
5. Design principles
6. Case series
7. Case-control study
8. Cohort study
9. Cross-section study
10. Clinical trials
11. Meta-analysis
12. Cost-effectiveness study
13. Diagnostic test evaluation
14. Reliability study
15. Database studies
16. Surveys and questionnaires
17. Qualitative methods and mixed methods?Definition of the study type

PART III: CLINICAL TRIALS
17. Randomized control
18. Nonrandomized control
19. Historical control
20. Cross-over
21. Withdrawal studies
22. Factorial design
23. Group allocation
24. Hybrid design
25. Large, pragmatic
26. Equivalence and noninferiority
27. Adaptive
28. Randomization
30. Multicenter considerations?Study design and practical considerations

PART IV: PLANNING
31. Optimizing the question
32. Meaningful outcome measurements?
33. Sample size?Power analysis
34. Budgeting?Funding, timeline, personnel, materials
35. Ethics and review boards?
36. Regulatory considerations for new drugs and devices?
37. Funding approaches?
38. Research team?
39. Subject recruitment?
40. Data management?
41. Quality control?
42. Report forms
43. Subject adherence?
44. Survival analysis?
45. Monitoring committee in clinical trials

PART V: STATISTICAL PRINCIPLES
46. Presenting data?
47. Common issues in analysis?
48. Basic statistical principles?
49. Distributions?Description, examples, implications in analysis.
50. Hypotheses and error types?
51. Power?Detecting effects
52. Regression?Explanation
53. t-test?Explanation
54. Chi-square?Explanation
55. Analysis of variance?Explanation
56. Correlation?Explanation
57. Biases?