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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 by their focus on practical aspects of study design that include the recruitment and consent process, as well as adherence and the use of routinely available equipment.

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A pragmatic study that involves a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for pragmatic trials to be reliable and reduce bias in results is also essential. However, too much heterogeneity can result in problems with the design of the trial.

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The aim of pragmatic trials is to mimic real-life scenarios and to achieve the highest level of validity externally. They are usually ordered by policymakers and practitioners in order to inform their decisions. They can also be used to determine the causal relationship between an intervention and its effects. They should not, however, be used to replace the need for explanation studies.

The pragmatism idea is controversial and there are concerns about whether pragmatic trials should be used to replace explanation tests or if they should be an addition to them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which confirm the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the features of a practical trial which includes the recruitment process, the design and delivery of the intervention, as well as monitoring.

There is a growing trend in the number of pragmatic trials that are published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to note, however, that the majority were conducted in primary-care settings.