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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized as focusing on practical aspects of study design, including the recruitment and consent process, as well as adherence and the use of routinely available equipment.

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A pragmatic trial that uses different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. A high degree of heterogeneity, however could cause issues with the design of the trial.

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The goal of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are usually requested by policy makers and practitioners to guide their decision-making. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. However, they should not be used as a substitute for explanatory trials.

The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate a physiological or clinical hypothesis and pragmatic trials that inform policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic study that includes recruitment, design, implementation of the intervention, and follow-up.

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