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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described by their focus on practical aspects of study design which include the recruitment process and consent, adhering and the use of routinely available equipment.

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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and included participants from different geographical regions. This kind of heterogeneity is necessary for pragmatic trials to be valid and also helps to reduce bias in the results. However, too much heterogeneity can result in issues with the design of the trial.

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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually commissioned by policy makers and practitioners to aid in their decision-making. They can also be used to determine the causal relationship between an intervention and its results. However, they should not be used in lieu for the use of explanation studies.

The pragmatism concept is controversial, and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate a physiological or clinical hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a practical trial that include the recruitment process, the design and implementation of the intervention, as well as follow-up.

There is a growing trend in the number of pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This is a sign that the health science community is becoming more acquaint to the subject of pragmatism. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.