Pragmatic Randomized Clinical Trials - by Cynthia J Girman & Mary E Ritchey (Paperback)

Book Synopsis

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.

Review Quotes

*5 stars* "...provides a comprehensive overview of pragmatic randomized clinical trials (RCTs). [C]ontents include the rationale, methodologies, and considerations for those who may consider conducting pragmatic RCTs.... [I]ntended for medical and graduate students, fellows in biostatistics and epidemiology, and health practitioners among the same disciplines.... [D]esigned to not only inform readers about pragmatic RCTs but also to provide necessary information for clinicians or researchers to conduct this style of clinical trials. [A]uthors offer detailed descriptions of considerations when conducting these trials such as approaches to mitigating biases and feasibility of data sources.... [A]n excellent resource for pragmatic RCTs.... I would recommend this book to any individual who is interested in conducting pragmatic RCTs or has a general interest in clinical trial research." --(c)Doody's Review Service, 2022, Victor Allen Soupene, MS (University of Iowa College of Public Health)