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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are typically described as focusing on practical aspects of study design, including the recruitment process and consent, adhering and 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 participants from different geographic areas. This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and reduces the chance of bias in the results. However excessive heterogeneity could lead to problems with the design of the trial.

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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve the highest level of validity externally. Usually, they are commissioned by policymakers and practitioners to help inform their decisions. They also provide a useful method to determine the causal relationship between an intervention and its outcomes. However, they should not, be used to replace explanatory 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 explanation trials, which confirm the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the policy and practice of. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic study that includes recruitment, design, delivery of the intervention, and follow-up.

There is a positive increase in the number pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs), yielded 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 pragmatic thinking. It is important to remember, however, that the majority were conducted in primary-care settings.