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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 described as a focus on the practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use of standard equipment.

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A pragmatic study that involves a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also helps to reduce the chance of bias in the results. 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 scenarios and to achieve maximum validity externally. Usually, they are commissioned by policymakers and practitioners to guide their decisions. They can be used to determine the causality of an intervention with its outcomes. They should, however, not, be used to replace explanatory studies.

The idea of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove a physiological or clinical hypothesis and pragmatic trials, which inform the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study which includes recruitment, design, implementation of the intervention, and follow-up.

There is a growing increase in the number of pragmatic trials that have been published. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary-care settings.