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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often described by their focus on practical aspects of study design which include the recruitment and consent process, as well as adherence 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 had participants from different geographical regions. This type of heterogeneity which is vital for a pragmatic trial to be reliable and reduce bias in results is also essential. However, too much heterogeneity could cause issues 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 requested by practitioners and policymakers in order to guide their decisions. They are also a good method to determine the cause-effect relationship between an intervention and its results. However, they should not, be used to replace the need for explanation studies.

The idea of pragmatism is controversial and there are concerns regarding whether pragmatic trials could replace explanatory tests or if they should be an addition to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform policy and practice decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic research study, including recruitment, design, delivery of the intervention, and follow-up.

There is an encouraging 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 is an indication that the health sciences community is becoming increasingly sensitized to the issue of pragmatism. However, it is important to note that the majority of these studies were conducted in primary care settings.