rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Pragmatic randomized clinical trials
    sub title: using primary data collection and electronic health records
  title info:
    title: Using primary data collection and electronic health records
  name:
    name part: Girman, Cynthia J.
    role:
      role term: editor.
  name:
    name part: Ritchey, Mary Elizabeth
    role:
      role term: editor.
  name:
    name part: Suárez, Elizabeth
    name part: 1962-
    role:
      role term: editor.
  name:
    name part: ScienceDirect (Online service)
  type of resource: text
  genre: bibliography
  genre: Electronic books.
  origin info:
    place:
      place term: enk
    date issued: 2021
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource (xxii, 476 pages) : charts
  abstract: 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.
  table of contents: 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 …
  note: edited by Cynthia J. Girman, Mary Elizabeth Ritchey ; assistant editor, Elizabeth A. Suarez.
  note: Includes index.
  note: Includes bibliographical references and index.
  subject:
    geographic code: n-us---
  subject:
    topic: Clinical trials
  subject:
    topic: Clinical immunology
    topic: Research
  subject:
    topic: Clinical immunology
    topic: Research
    geographic: United States
  subject:
    topic: Immunology
    topic: Research
  subject:
    topic: Immunology
    topic: Research
    geographic: United States
  subject:
    topic: Immunology
    topic: Data processing
  subject:
    topic: Medical records
    topic: Data processing
  subject:
    topic: Epidemiology
    topic: Research
  subject:
    topic: Epidemiology
    topic: Research
    geographic: United States
  subject:
    topic: Études cliniques
  subject:
    topic: Immunologie clinique
    topic: Recherche
  subject:
    topic: Immunologie clinique
    topic: Recherche
    geographic: États-Unis
  subject:
    topic: Immunologie
    topic: Recherche
  subject:
    topic: Immunologie
    topic: Recherche
    geographic: États-Unis
  subject:
    topic: Immunologie
    topic: Informatique
  subject:
    topic: Dossiers médicaux
    topic: Informatique
  subject:
    topic: Medical records
    topic: Data processing
  subject:
    topic: Immunology
    topic: Research
  subject:
    topic: Immunology
    topic: Data processing
  subject:
    topic: Epidemiology
    topic: Research
  subject:
    topic: Clinical trials
  subject:
    geographic: United States
  classification: R853.C55
  classification: 610.724
  related item:
    identifier: (OCoLC)1108524084
  identifier: 9780128176641
  identifier: 0128176644
  identifier: 9780128176634
  identifier: 0128176636
  identifier: 9780128176641 Ingram Content Group
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: YDX
    record creation date: 210413
    record change date: 20260327170237.0
    record identifier: in00005768137
    language of cataloging:
      language term: eng