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Pragmatic trials are studies designed to inform the practice of clinical trials in real life. They are typically focused on the practical aspects of study design, such as the recruitment and consent process 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 used various investigators and participants from different geographical regions. This type of heterogeneity is essential for practical trials to be valid, and it also helps to reduce bias in the results. However too much heterogeneity could lead to issues with the design of the trial.

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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 typically commissioned by policy makers and practitioners to inform their decision making. They can also be used to assess the causal relationship between an intervention and its results. However, they should not be used to replace the need for explanation studies.

The pragmatism idea is controversial and there are doubts about whether pragmatic trials should be used to replace explanation tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the validity of a clinical or physiological hypothesis and pragmatic trials that inform the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic study that includes recruitment, design, delivery of the intervention, and follow-up.

The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) resulted in 34 articles, shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to remember that the majority were conducted in primary-care settings.