Living Textbook

May 19, 2020: New Updates to What is a Pragmatic Clinical Trial Chapter in the Living Textbook

Posted on by Gina Uhlenbrauck

The NIH Collaboratory regularly refreshes content in the Living Textbook in order to offer a robust collection of resources to the wider research community about how to plan and implement a pragmatic clinical trial. We invite you to explore recent additions to the introductory chapter What Is a Pragmatic Clinical Trial?

Highlights include information on the broader embedded PCT (ePCT) ecosystem, an updated table describing the 19 NIH Collaboratory Trials, a new illustration of the PRECIS-2 continuum, webinars on how to start a PCT, and more.

“The Living Textbook reflects a collection of expert consensus regarding special considerations, standard approaches, and best practices in the design, conduct, and reporting of PCTs.” – Dr. Kevin Weinfurt, Editor-in-Chief of the Living Textbook

Sections in What is a Pragmatic Clinical Trial include:

  1. Why Are We Talking About Pragmatic Trials?
  2. The Embedded Pragmatic Clinical Trial Ecosystem
  3. Differentiating Between RCTs, PCTs, and Quality Improvement Activities
  4. Pragmatic Elements: An Introduction to PRECIS-2
  5. Key Considerations for PCTs
  6. Additional Resources

April 13, 2020: New Living Textbook Chapter on Pragmatic Mobile Health (mHealth) Trials

Posted on by Damon Seils

A new chapter in the Living Textbook provides expert advice for investigators considering using mobile technologies in pragmatic clinical trials. The chapter outlines many of the possibilities, advantages, and challenges associated with mobile health (mHealth) interventions, with a particular focus on design and evaluation of these programs in pragmatic clinical trials.

“We will illustrate many design and evaluation challenges, culminating with a discussion of how these considerations influence the ongoing development of the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) project.”—Real-World Evidence: Mobile Health (mHealth)

For more on using real-world evidence in pragmatic trials, see the Living Textbook chapter Choosing and Specifying Endpoints and Outcomes.

March 3, 2020: Healthcare System Leaders Give Advice to Pragmatic Trial Investigators

Posted on by Karen Staman

In a new section of the Living Textbook on Building Partnerships to Ensure a Successful Trial, Kenneth Sands, the chief epidemiologist and chief patient safety officer at HCA, and Jonathan Perlin, the chief medical officer and president of clinical services at HCA, offer advice to investigators who wish to conduct pragmatic clinical trials.

“Healthcare systems have constrained bandwidth, and participating in learning activities involves significant costs and challenges: there are direct costs but also intangible costs, which can be substantial, such as personnel time, IT time, distraction of clinical staff, and the potential for supply chain issues.” — Advice from Healthcare System Leadership

The authors establish principles of partnership that include establishing and maintaining a durable partnership, selecting topics of mutual interest, and giving precedence to operational imperatives.

For more, see the article “Real-World Advice for Generating Real-World Evidence” in NEJM Catalyst.

January 28, 2020: A New Way to Navigate the Living Textbook

Posted on by Damon Seils

Readers have a new way to navigate the NIH Collaboratory’s Living Textbook of Pragmatic Clinical Trials. A Table of Contents now offers a comprehensive overview of the Living Textbook’s evolving content on the design, conduct, and dissemination of pragmatic clinical trials embedded in healthcare systems.

The Living Textbook is frequently updated with new content. Recent additions include sections on using death as an endpoint, challenges associated with missing data in intention-to-treat analyses, and using inpatient endpoints in pragmatic trials.

The NIH Collaboratory recently announced a special Living Textbook Grand Rounds series. The series begins Friday, January 31st, with “Pragmatic Clinical Trials: How Do I Start?”

January 24, 2020: Special Grand Rounds Series Begins January 31st With ‘Pragmatic Clinical Trials: How Do I Start?’

Posted on by Gina Uhlenbrauck

Join us Friday, January 31st, for “Pragmatic Clinical Trials: How Do I Start?”—the first in our special 5-part Grand Rounds series focused on the Living Textbook. NIH Collaboratory investigators Dr. Greg Simon and Dr. Lesley Curtis will offer guidance on what researchers need to begin an embedded pragmatic clinical trial, including:

  • Developing your research question
  • Establishing close partnerships with participating healthcare system leaders and staff
  • Putting together your trial team

Visit our events calendar here for details about how to join this webinar. See below for the full schedule of sessions and a special message from Dr. Kevin Weinfurt.

Full Schedule of sessions

Title Speakers Date
Pragmatic Clinical Trials:
How Do I Start?		 Greg Simon, MD, MPH, KPWHRI

Lesley Curtis, PhD, Duke University

 January 31, 2020
Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts Jerry Jarvik, MD, MPH, University of Washington

Vince Mor, PhD, Brown University

Leah Tuzzio, MPH, KPWHRI

 February 28, 2020
Tips for Putting Together a Successful PCT Grant Application Wendy Weber, ND, PhD, MPH, NCCIH March 27, 2020
Choosing What to Measure
and Making It Happen: Your Keys to Pragmatic Trial Success		 Rachel Richesson, PhD, MPH, Duke University

Emily O’Brien, PhD, FAHA, Duke University

 May 1, 2020
Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials Liz Turner, PhD, Duke University

Patrick Heagerty, PhD, University of Washington

David Murray, PhD, NIH

 June 19, 2020

 

December 20, 2019: Embedded Pragmatic Clinical Trials: From Idea to Funding to Implementation: A Living Textbook Grand Rounds Series

Posted on by Gina Uhlenbrauck

Coming in 2020, the NIH Collaboratory will host a 5-part Grand Rounds Series focused on the Living Textbook. The series will feature Collaboratory expert speakers guiding the audience through the life cycle of an ePCT by way of the textbook—from idea to funding to implementation.

The series begins January 31 with “Pragmatic Clinical Trials: How Do I Start?” and will end June 19 with “Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials.”

See below for the full schedule of sessions and a special message from Dr. Kevin Weinfurt.

Full Schedule of sessions

Title Speakers Date
Pragmatic Clinical Trials:
How Do I Start?		 Greg Simon, MD, MPH, KPWHRI

Lesley Curtis, PhD, Duke University

 January 31, 2020
Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts Jerry Jarvik, MD, MPH, University of Washington

Vince Mor, PhD, Brown University

Leah Tuzzio, MPH, KPWHRI

 February 28, 2020
Tips for Putting Together a Successful PCT Grant Application Wendy Weber, ND, PhD, MPH, NCCIH March 27, 2020
Choosing What to Measure
and Making It Happen: Your Keys to Pragmatic Trial Success		 Rachel Richesson, PhD, MPH, Duke University

Emily O’Brien, PhD, FAHA, Duke University

 May 1, 2020
Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials Liz Turner, PhD, Duke University

Patrick Heagerty, PhD, University of Washington

David Murray, PhD, NIH

 June 19, 2020

 

We hope you will join us to learn more about the fundamentals for designing and launching a successful ePCT. Please download the flyer for the Living Textbook Grand Rounds series and share with your colleagues and institution.

September 23, 2019: NIH Collaboratory Seeks Feedback on the Living Textbook

Posted on by Damon Seils

The NIH Collaboratory Coordinating Center launched an online survey to collect feedback from clinical investigators, healthcare system partners, and the broader research community about the Living Textbook of Pragmatic Clinical Trials. Responses to the survey will help the Coordinating Center enhance its resources for users interested in pragmatic research.

“We are eager to receive feedback on our signature resource, the Living Textbook,” said Dr. Kevin Weinfurt, co–principal investigator of the NIH Collaboratory Coordinating Center. “This feedback will help us achieve our goal of better enabling researchers to build partnerships with healthcare systems and transform how clinical research is conducted.”

The purpose of the Living Textbook, the NIH Collaboratory’s publicly available online resource at rethinkingclinicaltrials.org, is to share expert consensus regarding standard approaches, best practices, and special considerations in the design, conduct, and reporting of pragmatic clinical trials. The Living Textbook also provides information about the NIH Collaboratory program, its NIH Collaboratory Trials, and related initiatives.

The online survey will remain open until October 31, 2019.

February 21, 2019: Living Textbook Offers New Content on Design and Analysis of Pragmatic Clinical Trials

Posted on by Damon Seils

Members of the NIH Collaboratory’s Biostatistics and Study Design Core contributed 3 new sections to the Living Textbook exploring issues in the design and analysis of pragmatic clinical trials. The new sections offer insights into emerging issues in embedded pragmatic clinical trials and lessons learned from the NIH Collaboratory’s first round of NIH Collaboratory Trials.

  • The Designing to Avoid Identification Bias section addresses a type of selection bias that can occur in pragmatic clinical trials that use information from electronic health records to determine study population eligibility and in which the study intervention influences who undergoes screening or receives a diagnosis in clinical care.
  • The Alternative Cluster Randomized Designs section describes alternative design choices for cluster randomized trials and their implications for statistical power and sample size calculations. Modified cluster randomized designs, such as cluster randomization with crossover, may reduce the sample size required for a pragmatic clinical trial and may be particularly feasible in trials embedded in healthcare systems with electronic health records.
  • Case Study: STOP CRC Trial explores challenges in design and analysis that were faced in the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, one of the NIH Collaboratory Trials. The case study illustrates how the study team dealt with pragmatic issues during the planning and conduct of the trial.

In addition to contributing content to the Living Textbook, the Biostatistics and Study Design Core works with the NIH Collaboratory Trials to address challenges in their statistical plans and study designs during the planning phase and to develop guidance and technical documents related to study design and biostatistical issues relevant to pragmatic clinical trials.