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Pragmatic trials are those that are designed to provide information for the real-world practice of clinical. They are typically characterized by a focus on the practical aspects of the study design, including recruitment and consent, adherence, and the use of routinely available equipment.
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A practical trial that employs different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for practical trials to be valid and helps reduce bias in the results. However too much heterogeneity could result in issues with the design of the trial.
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The aim of pragmatic trials is to replicate real-life situations and achieve maximum validity externally. They are usually requested by practitioners and policy makers to inform their decision making. They are also a good method to determine the causality between the intervention and its effects. They should not, however be used to replace explanatory studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials can replace explanatory tests or if they are an addition to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis, and pragmatic trials, which inform policy and practice decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a practical trial which includes recruitment, design and delivery of the intervention, as well as the follow-up.
There is a positive trend in the number of pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health science community is becoming more sensitive to the issue of pragmatism. However, it is important to note that the majority of these studies were conducted in primary care settings.