Translational Gastroenterology

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.

List 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 datä
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¿

About the author

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.
Dr Liu obtained his PhD in Biostatistics from the University of Pennsylvania.?Dr Liu is Associate Professor of Biostatistics and?Director of the Brown ARCH Data and Statistics Core. He also is a faculty member at the biostatistics core of the Lifespan/Boston/Brown Center for AIDS Research (CFAR), Brown Data Science Initiative (DSI), Advance-Clinical?Translational Research (Advance-CTR)?and an affiliated faculty member for the AMPATH Biostatistics and Data Program. His research interests are in the area of health data science and include clinical decision making, incomplete data problems, causal inference, diagnostic testing, and design of clinical trials.Devendra Mehta is a Pediatric Gastroenterologist, Director of the Translational GI Laboratory at Orlando Health Arnold Palmer Children’s Hospital, and the program director of the Pediatric GI and Nutrition Fellowship. He underwent training at St Thomas’ Hospital, now part of Kings College in London, UK, in Medicine, with further training at the Hospital for Sick Children, Toronto, Guys Hospital, London, UK, London School of Tropical Medicine and Hygiene (MSc Distinction) and Hahnemann University, Philadelphia for the Pediatric GI Fellowship. He has a special interest in developing biomarkers to aid the diagnostics of disorders and has studied a wide array of disorders including aspiration, Gastroesophageal reflux disease, Eosinophilic esophagitis, Helicobacter Pylori infection, Celiac Disease, Small bowel microbial overgrowth, Inflammatory Bowel Disease, Irritable Bowel Syndrome and Constipation, and produced many abstracts, presentations, papers and chapters in books. He directs and studies the integrative medicine clinic which uses Yoga and Meditation for chronic disorders, and the regional Feeding difficulty center. He has been recognized as a “Best Doctor” consistently and is on the board, and former President, of Central Florida Child Health Program, Inc., a non-profit organization. He has further responsibilities in research as the Chair of the Research Advisory Committee to help optimize studies and as faculty for the Biostatistics program for fellows. He has two patents and continues to work in national collaboratives such as in childhood and adult pancreatic disorders and Inflammatory Bowel Disease.
Karoly Horvath, M.D., Ph.D. has been pediatric gastroenterologist since 1980. He graduated and received his Ph.D. degree in Hungary. Since 1990 he has been worked in US in a few academic medical centers, including the Hahnemann University in, Philadelphia, the University of Maryland at Baltimore, A.I duPont Hospital for Children affiliated to Jefferson Medical University and finally at Arnold Plamer Hospital for children. His commitment to education is shown that he established two successful pediatric gastroenterology training programs. First at University of Maryland in 2000 and the second at the Orlando Health in 2011.
His research is mainly translational in nature. He founded a CLIA certified Pediatric Gastroenterology Specialty Laboratory 1993 that introduced unique clinical tests and assisted to set and other one In Delaware. He has 102 peer-reviewed publications, 31 book chapters, he has over 5000 citations, presented 54 invited lectures and author and coeditor of Pediatric Gastroenterology book.

Product details

• Assisted by: Adam E.M. Eltorai (Editor), Karoly Horvath (Editor), Liu Tao (Editor), Devendra Mehta (Editor)
• Publisher: Elsevier
• Languages: English
• Product format: Paperback / Softback
• Released: 16.06.2025
• EAN: 9780128214268
• ISBN: 978-0-12-821426-8
• Weight: 450 g
• Series: Handbook for Designing and Conducting Clinical and Translational Research
• Subjects: Natural sciences, medicine, IT, technology > Biology > General, dictionaries; SCIENCE / Life Sciences / General, MEDICAL / Gastroenterology, SCIENCE / Life Sciences / Biology, Biology, life sciences, Life sciences: general issues