Pragmatic Randomized Clinical Trials: Using Primary Data Collection and Electronic Health Records

ISBN-13: 9780128176634 / Angielski / Miękka / 2021 / 500 str.

Cynthia J. Girman; Mary Elizabeth Ritchey

Spis treści

Acknowledgements Preface Robert Califf and Joe SelbyI: 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 SturmerIV: 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 ZhouV: Privacy and Ethics 19. Considerations for Protecting Research Participants Aisling CaffreyVI: 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