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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically focused on the practical aspects of the research design, like the recruitment and consent process as well as adherence to 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 employed a variety of investigators and participants from various geographical areas. This type of heterogeneity is required for pragmatic trials to be able to prove their validity and helps reduce the chance of bias in the results. However, too much heterogeneity could cause issues with the trial design.

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The aim of pragmatic trials is to mimic real-life situations and achieve the highest level of validity externally. They are usually requested by practitioners and policymakers to inform their decisions. They are also a good method of determining the cause-effect relationship between an intervention and its results. However, they should not, be used to replace explanatory studies.

The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace tests for explanations or if they should serve as an addition to them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic study that includes recruitment, design, delivery of the intervention and follow-up.

There is a growing increase in the number of pragmatic trials that are published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to remember that the majority of these studies were conducted in primary care settings.