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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized by their focus on practical aspects of design that include the recruitment process and consent, adhering and the use of routinely available equipment.

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A pragmatic trial that uses different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, that is crucial for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. However excessive heterogeneity could lead to problems with the design of the trial.

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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are typically commissioned by policymakers and practitioners to help inform their decisions. They can also be used to determine the causality of an intervention and its results. However, they should not be used in lieu for explanation studies.

The pragmatism idea is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic study which includes recruitment, design, delivery of the intervention and its follow-up.

There is a growing trend in the number of pragmatic trials that have been published. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the issue of pragmatism. It is important to note, however, that the majority were conducted in primary care settings.