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

Cynthia J. Girman , Mary E. Ritchey 지음

elsevier 2021년 04월 23일 출간

작품소개

책소개

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

목차

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 St킥rmer 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

작가정보

저자(글) Cynthia J. Girman

저자(글) Mary E. Ritchey