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Translational Gastroenterology

  • 1st Edition - April 18, 2025
  • Latest edition
  • Editors: Adam E.M. Eltorai, Tao Liu, Devendra Mehta, Karoly Horvath
  • Language: English

Translational Gastroenterology covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. Readers will learn… Read more

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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.

Key features

  • 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

Readership

Basic scientists interested in translating their research into clinical practice, gastroenterologists and masters programs in clinical investigation

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

Product details

  • Edition: 1
  • Latest edition
  • Published: May 30, 2025
  • Language: English

About the editors

AE

Adam E.M. Eltorai

Dr 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

TL

Tao Liu

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.
Affiliations and expertise
Associate Professor of Biostatistics and Director of the Brown ARCH Data and Statistics Core, Brown University, USA

DM

Devendra Mehta

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.

Affiliations and expertise
Florida State University, Arnold Palmer Hospital at Orlando Health, Orlando, FL, USA

KH

Karoly Horvath

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.

Affiliations and expertise
Karoly Horvath, M.D., Ph.D. Clinical Professor of Pediatrics, Florida State University, Pediatric Gastroenterology Attending, Director of Pediatric Gastroenterology Training Program, Center for Digestive Health and Nutrition, Arnold Palmer Hospital for Children, Orlando Health, Orlando, Florida.

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