Curbside Consults Podcast

Published November 26, 2019

Practical or pragmatic trials are designed to show the effectiveness of an intervention in the complex clinical setting of daily practice. But what makes a trial pragmatic? Can a clinical trial ever be completely pragmatic? Join us in this episode of Curbside Consults with Dr. David Harrington, statistical editor at the NEJM, as we discuss the elements, strengths, and drawbacks of pragmatic trial design.

00:00 Introduction
00:50 Learning objectives
01:05 Summary of Hajek et al. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy
02:08 Assessing the pragmatic trial based on the pragmatic features of the trial
02:54 The Pragmatic–Explanatory Continuum Indicator Summary (PRECIS) tool to assess pragmatic features of a trial
03:36 Pragmatism in recruitment of investigators and participants
04:43 Pragmatism in the study intervention and its delivery within the trial
06:19 Pragmatism in the nature of study follow-up
08:20 Pragmatism in nature, determination, and analysis of study outcomes
09:15 Is this a pragmatic trial?
09:36 Why conduct a pragmatic trial?
09:58 When to design a trial to be less pragmatic?
10:18 Overall approach to assessing trials that claim to be pragmatic

Additional Resources:
1. Hajek et al. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. N Engl J Med 2019.
2. Ian Ford and John Norrie. Pragmatic Trials. N Engl J Med 2016.

The Curbside Consults series complements the foundational information in NEJM R360 Rotation Prep by taking a deep dive into key clinical topics with expert clinicians and educators. These podcasts explore and critique the evidence behind clinical practice and break down statistical concepts for the busy clinical trainee.

David Harrington is Emeritus Professor of Biostatistics and Statistics at Harvard T.H. Chan School of Public Health
Angela Castellanos is a general pediatrician and editorial fellow at the NEJM.