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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are typically described as a focus on the practical aspects of design which include the recruitment process and consent, adhering and the use of routinely available equipment.
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A pragmatic study that involves different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is vital for a pragmatic trial to be reliable and to reduce bias in the results is also essential. A high degree of heterogeneity, however, can cause problems with the trial design.
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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. Usually, they are commissioned by policymakers and practitioners to help inform their decisions. They can be used to determine the causality of an intervention with its outcomes. However, they shouldn't be used to substitute for explanation trials.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials can replace explanatory tests or if they should serve as an alternative to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool attempted to define the elements of a pragmatic study, including the recruitment process, the design and implementation of the intervention, as well as follow-up.
There is an encouraging trend in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (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 subject of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.