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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 often described as a focus on the practical aspects of study design which include the recruitment and consent process, as well as adherence and the use routinely available equipment.

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A pragmatic trial that uses different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is vital for pragmatic trials to be valid and reduce bias in results, is also necessary. However excessive heterogeneity could lead to problems with the design of the trial.

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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually requested by practitioners and policy makers to guide their decision-making. They can also be a great way to identify the causal relationship between an intervention and its outcomes. They should, however, not be used to replace explanation studies.

The pragmatism concept is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate a physiological or clinical hypothesis, and pragmatic trials that inform the practice and policy decisions. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the characteristics of a pragmatic study that include the recruitment process, the design and delivery of the intervention, and follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these trials were conducted in primary care settings.