http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
using primary data collection and electronic health records
1 online resource (xxii, 476 pages) : charts
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.
Acknowledgements -- Preface / Robert Califf and Joe Selby -- I: Introduction. 1. Introduction to pRCTs / Cynthia J. Girman and Mary Elizabeth Ritchey ; 2. The Efficacy-Effectiveness Gap / Rolf H.H. Groenwold ; 3. Studies for labeling vs reimbursement / Robert Epstein -- II: Patient Voice and Stakeholder Feedback. 4. Stakeholder Engagement in pRCT Design and Conduct / Thomas Concannon ; 5. Patient Voice in Clinical Trial Programs in Industry / Jeanne M. Regnante -- III: Design & Analysis. 6. What is the research question? / Elizabeth A. Suarez and Soko Setoguchi ; 7. Feasibility assessment for use of EHR / Mary Elizabeth Ritchey ; 8. Important design considerations in pRCTs / Kevin Thorpe ; 9. Randomization and Blinding - Randomization at what unit? Blinding of who and what? / Jennifer Christian ; 10. Cluster Randomized Trials / Katherine Harris ; 11. Design and Analytic Approaches to Minimize Bias and Confounding / Michele Jonsson Funk ; 12. Sensitivity analyses / Elizabeth A. Suarez and Cynthia J. Girman ; 13. Methodology and Reporting Guidelines / Aisling Caffrey ; 14. Unmeasured Confounding with and without randomization / Phyo Than Htoo and Til Stűrmer -- IV: Operational Aspects ; 15. Validation of Electronic Health Record and Patient-Reported Outcomes / Vincent Lo Re III ; 16. Special Considerations in EHR / Leah McGrath and Jenna Wong ; 17. Distributed Networks of Electronic Health Record Data / Catherine A. Panozzo ; 18. International and global issues - differences in medical practice / Ju-Young (Judy) Shin, Kenneth Man and Wei Zhou -- V: Privacy and Ethics. 19. Considerations for Protecting Research Participants / Aisling Caffrey -- VI: Interpretation, Limitations, and Strengths. 20. Replication and reproducibility / Kristy Iglay and Mary Elizabeth Ritchey -- VII: Dissemination. 21. Communicating results to patients for shared decision-making / Wendy Camelo Castillo ; 22. Communicating Results of pRCTs to the Medical Community / Joe Selby and Timothy Carey ; 23. Communicating to regulatory agencies / Larry D. Alphs -- VIII: Special Considerations on Interventions ; 24. Biologics / Jaclyn L. F. Bosco and Priscilla Velentgas ; 25. Medical Devices / Mary Elizabeth Ritchey ; 26. Rare Diseases / Cunlin Wang and Lina Titievsky ; 27. Behavioral Interventions / Andrea Troxel -- IX: Case Studies. 28. Examples from Primary Data Collection / Kourtney J. Davis and Jeanne Marie Pimenta ; 29. Examples from Electronic Health Records and Administrative Claims Data / Ehab Hasan ; 30. Use of Pragmatic Randomized Clinical Trials in Reimbursement Decisions / Kati Copley-Merriman -- X: Conclusions. 31. Concluding remarks / Cynthia J. Girman, Mary Elizabeth Ritchey and Elizabeth A. Suarez.
edited by Cynthia J. Girman, Mary Elizabeth Ritchey ; assistant editor, Elizabeth A. Suarez.
Includes bibliographical references and index.