Pragmatic Randomized Clinical Trials
eBook - ePub

Pragmatic Randomized Clinical Trials

Using Primary Data Collection and Electronic Health Records

  1. 498 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Pragmatic Randomized Clinical Trials

Using Primary Data Collection and Electronic Health Records

About this book

Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation, and dissemination of pragmatic randomized trials, also sometimes referred to as practical or hybrid randomized trials. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. The book contains chapters encompassing common designs along with advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize pragmatic randomized trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed.This comprehensive resource is valuable not only for pharmacoepidemiologists, biostatisticians and clinical researchers, but also across the biomedical field for those who are interested in applying pragmatic randomized clinical trials in their research. - Addresses typical designs and challenges of pragmatic randomized clinical trials (pRCTs) - Encompasses analytic aspects of such trials - Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records

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Yes, you can access Pragmatic Randomized Clinical Trials by Cynthia J. Girman,Mary E. Ritchey in PDF and/or ePUB format, as well as other popular books in Biological Sciences & Biology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Academic Press
Year
2021
Print ISBN
9780128176634
eBook ISBN
9780128176641
Topic
Biological Sciences
Subtopic
Biology
Index
Biological Sciences

Table of contents

  1. Title of Book
  2. Cover image
  3. Title page
  4. Table of Contents
  5. Copyright
  6. Contributors
  7. Acknowledgments
  8. Preface
  9. Chapter 1 Introduction
  10. Chapter 2 The efficacy-effectiveness gap
  11. Chapter 3 Studies for labeling versus reimbursement
  12. Chapter 4 Stakeholder engagement in the design and conduct of pragmatic randomized trials
  13. Chapter 5 Patient voice in clinical trial programs in industry
  14. Chapter 6 What is the research question?
  15. Chapter 7 Evaluating the feasibility of data sources for pragmatic clinical trials
  16. Chapter 8 Important design considerations in Pragmatic Randomized Clinical Trials
  17. Chapter 9 Randomization and masking – randomization at what unit? Masking of who and what?
  18. Chapter 10 Design and analysis of cluster randomized trials
  19. Chapter 11 Approaches to mitigate bias in the design and analysis of pRCTs
  20. Chapter 12 Sensitivity analyses in pragmatic randomized clinical trials
  21. Chapter 13 Methodology and reporting guidelines
  22. Chapter 14 Unmeasured confounding with and without randomization
  23. Chapter 15 Validation of health outcomes of interest in healthcare databases
  24. Chapter 16 Special topics in electronic health data: missing data and unstructured data
  25. Chapter 17 Distributed research networks and applications to pragmatic randomized trials
  26. Chapter 18 International and global issues – differences in health systems, patient populations, and medical practice
  27. Chapter 19 Considerations for protecting research participants
  28. Chapter 20 Replication and reproducibility
  29. Chapter 21 Dissemination of pragmatic randomized clinical trials information and results to patients and community stakeholders
  30. Chapter 22 Communicating results of pRCTs to the medical community
  31. Chapter 23 The PRIDE study: A post-marketing prospective pragmatic randomized clinical trial with regulatory approval
  32. Chapter 24 Special considerations on interventions: biologics
  33. Chapter 25 Special considerations of interventions: Medical devices
  34. Chapter 26 Special topic: Rare disease
  35. Chapter 27 Pragmatic randomized trials for behavioral health or educational interventions
  36. Chapter 28 Case studies: Examples from primary data collection
  37. Chapter 29 Examples from administrative claims data and electronic health records
  38. Chapter 30 Use of pragmatic clinical trials in reimbursement decisions
  39. Chapter 31 The future of clinical trials
  40. Index