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Featured Module (Archived)
A new educational offering from the Intent & Question section of the curriculum wheel has been posted (1-1.5 hours of primary open access content).
This website will be updated every Monday (by 12:00 PM Eastern) or Tuesday (if Monday is a holiday). Given that the design, implementation, and management of pragmatic trials is a non-linear process, featured modules will relate to various sections of the curriculum wheel over time.
Intent & Question Section
The PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) Tool
Primary content:
Primary content:
Loudon K, et al. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. (11-page paper)
Summary: Provides guidance on how to use the PRECIS-2 tool (developed by more than 80 international trialists, clinicians, and policymakers). PRECIS-2 has nine domains: eligibility criteria, recruitment, setting, organization, flexibility (delivery), flexibility (adherence), follow-up, primary outcome, and primary analysis - scored from 1 (very explanatory) to 5 (very pragmatic). The PRECIS-2 tool supports in matching specific design decisions to the intention of the trial.
NIH Pragmatic Trials Collaboratory (Living Textbook): Section 4 - Pragmatic Elements: An Introduction to PRECIS-2 (Chapter: Design - What is a pragmatic clinical trial?): 7-min webinar & 1-page website.
Summary: Dr. Lesley Curtis (webinar) overviews the Pragmatic–Explanatory Continuum and the PRECIS-2 wheel. The related website describes characteristics and examples of research questions, settings, participants, interventions and comparators, and outcomes you may find in a trial that is more pragmatic in intention (vs. explanatory).
NIH Pragmatic Trials Collaboratory - Pragmatic and Explanatory Attitudes to RCTs: Using the PRECIS-2 Tool to Describe the Design of the MyTEMP Trial (November 13, 2020): 1-hour webinar (45-slide presentation).
Summary: Drs. Zwarenstein, Garg, and Al-Jaishi provide an overview of the PRECIS-2 tool, highlight explanatory vs. pragmatic design choices, and do a comparison, using the PRECIS-2 tool, of two trials of dialysis temperatures (i.e., contrasting an explanatory trial with individual-level randomization vs. a pragmatic trial with cluster-level randomization).
Optional content:
Optional content:
NIH Pragmatic Trials Collaboratory (Living Textbook): Section 5 - PRECIS-2 Case Study (Chapter: Design - What is a pragmatic clinical trial?): 1-page website.
Summary: Provides a concise summary of the “Using the PRECIS-2 Tool to Describe the Design of the MyTEMP Trial (November 13, 2020)” presentation.
HRB Trials Methodology Research Network (HRB-TMRN & UCC CRF-C Study Day) - Measuring pragmatism - PRECIS-2 and moving towards PRECIS-3 (November 9, 2021): 19-min webinar.
Summary: Alison Howie overviews the PRECIS-2 domains (eligibility, recruitment, setting, organization, flexibility: delivery, flexibility: adherence, follow-up, primary outcome, primary analysis) and uses the tool in the context of a published pragmatic trial.
Johnson KE, et al. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. (11-page paper)
Summary: Describes an analysis using the PRECIS-2 tool on five NIH Collaboratory pragmatic trials to better understand (1) the pragmatic aspects of the design and implementation of interventions delivered in real-world settings and (2) the usability of the PRECIS-2 tool for assessing pragmatic elements.
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