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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 which include recruitment and consent, adherence and the use of routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and had participants from different geographical regions. This type of heterogeneity is required for practical trials to be valid and also helps reduce the chance of bias in the results. Too much heterogeneity, however could cause issues with the trial design.

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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are typically requested by practitioners and policymakers to inform their decisions. They can also be used to assess the causality of an intervention and its effects. However, they should not be used as a substitute for explanatory studies.

The pragmatism idea is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis and pragmatic trials, which inform policy and practice decisions. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the characteristics of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, as well as monitoring.

There is an encouraging trend in the number of pragmatic trials 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 is an indication that the health science community is becoming more acquaint to the issue of pragmatism. However, it is important to note that the majority of these trials were conducted in primary care settings.