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Pragmatic trials are those that are designed to inform real-world clinical practice. They are often characterized by a focus on the practical aspects of the study design, including the recruitment and consent process, adherence, and the use of standard equipment.
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A practical trial that employs different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity that is crucial for a pragmatic trial to be reliable and to reduce bias in the results, is also necessary. However, too much heterogeneity can result in problems with the trial design.
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The aim of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. They are usually ordered by policymakers and practitioners to guide their decisions. They can also be used to determine the causality of an intervention and its results. However, they shouldn't be used in lieu for the use of explanation trials.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis and pragmatic trials, which guide policy and practice decisions. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a pragmatic trial which includes the recruitment process, the design and delivery of the intervention, and monitoring.
There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, shown in red in Figure 2. This is an indication that the health sciences community is becoming more acquaint to the issue of pragmatics. It is important to keep in mind that the majority of these trials were conducted in primary care settings.
