In Section I, the purpose and defining characteristics of pragmatic research are described.
In Section II, the fundamental concepts of PRECIS are outlined, and the domains of PRECIS-2 listed. Section two also contains an interactive “PRECIS Wheel” diagram.
Section V will help a reader to understand and apply statistical considerations to pragmatic trial research design.
In Section III, the importance of stakeholder identification, engagement and inclusion in plan development and dissemination are addressed.
Section IV addresses the unique characteristics of study population and setting as applied to pragmatic trials.
The objective of section VI is to understand and resolve the tension between intervention fidelity and adaptation, which is often a key to success in real world application.
The “Case Example” section is an opportunity for the reader to apply what they’ve learned to a specific example, then compare their methods to those selected by our investigators.
Welcome!
Closing the gap between research discovery and clinical and community practice is essential if we are to succeed in improving our nation’s health.
Pragmatic trials are randomized controlled studies whose purpose is to inform decisions about practice. They address questions of major clinical and public health importance and produce results that can be generalized and applied in usual care settings. Because they produce real-world evidence, they help to close the translation gap between discovery and practice.
In this training workbook, we present the PRagmatic-Explanatory Continuous Indicator Summary (PRECIS-2) as a framework for systematically designing and reporting pragmatic trials. The nine PRECIS-2 domains will be discussed in three modules: Study Populations and Setting, Research Design, and Real-World Use. In addition, we will highlight methods for patient and stakeholder engagement, an important component of pragmatic research.
This workbook is designed to be a navigation guide providing key references and online resources to aid you in further study and application.
We are excited about the national pragmatic trial experts who are part of the workshop. We look forward to your feedback and the pragmatic research community we are forging together in Colorado!
Russ Glasgow, PhD
Director, Colorado Research on Implementation Science Program (CRISP)
Elaine Morrato, DrPH, MPH
Director, Pragmatic Trials and D/I Unit, Colorado Clinical &Translational Sciences Institute (CCTSI)
Allison Kempe, MD, MPH
Director, Adult and Child Center for Health Outcomes Research and Delivery Science (ACCORDS)
Supported by: Agency for Healthcare Research and Quality (AHRQ) Department of Health and Human Services Research Program Project, Grant Number 5P01HS021138-03. Contents are the authors’ sole responsibility and do not necessarily represent official AHRQ views.
Planning Faculty: Russ Glasgow, Elaine Morrato, Borsika Rabin and Chase Cameron
Collaborating Agencies:
Center for Research in Implementation Science and Prevention (CRISP)
Colorado Clinical & Translational Sciences Institute (CCTSI)
Ischemic Heart Disease Quality Enhancement Research Initiative
Veteran Administrations Eastern Colorado Health Care System