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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are often characterized by their focus on practical aspects of study design which include the recruitment and consent process, as well as adherence and the use of routinely available equipment.

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A pragmatic study that involves different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, that is crucial for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. A high degree of heterogeneity, however could cause issues with the design of the trial.

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The purpose of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are usually requested 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 effects. However, they shouldn't be used in lieu for explanatory studies.

The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide policy and practice decisions. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool sought to define the features of a pragmatic study, including the recruitment process, the design and implementation of the intervention, as well as monitoring.

There is a growing increase in the number pragmatic trials that are published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the issue of pragmatic thinking. It is important to keep in mind that the majority of these trials were conducted in primary care settings.