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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically characterized by a focus on the practical aspects of research design, like recruitment and consent in adherence, as well as the use of standard equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and had participants from various geographical areas. This type of heterogeneity which is essential for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. However, too much heterogeneity, can cause problems with the trial design.

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The aim of pragmatic trials is to replicate real-life situations and achieve maximum validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can also be used to determine the causal relationship between an intervention and its effects. However, they should not, be used to replace explanation studies.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the clinical or physiological hypothesis and pragmatic trials, which guide the policy and practice of. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the elements of a pragmatic trial that include recruitment, design and delivery of the intervention, as well as monitoring.

There is a growing trend in the number of pragmatic trials 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 indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note that the majority of these trials were conducted in primary care settings.