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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are usually characterized by a focus on practical aspects of the study design, such as recruitment and consent in adherence, as well as 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 utilized different investigators and included participants from various geographical areas. This kind of heterogeneity is necessary for pragmatic trials to be valid and also reduces bias in the results. However too much heterogeneity could result in issues with the design of the trial.

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The goal of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They are also a good method of determining the cause-effect relationship between an intervention and its results. They should not, however, be used to replace the need for explanation studies.

The pragmatism concept is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis and pragmatic trials that inform the practice and policy decisions. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool attempted to define the characteristics of a pragmatic trial which includes recruitment, design and delivery of the intervention, and follow-up.

There is a growing trend in the number of pragmatic trials published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.