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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized as focusing on practical aspects of study design, including recruitment and consent, adherence and the use of standard 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 too much heterogeneity could lead to issues with the design of the trial.

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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by practitioners and policy makers to guide their decision-making. They also provide a useful way to identify the cause-effect relationship between an intervention and its results. They should not, however, be used to replace the need for explanation studies.

The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate a physiological or clinical hypothesis as well as pragmatic trials, which inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic study that includes the recruitment, design, and delivery of the intervention and follow-up.

There is a growing increase in the number pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) produced 34 articles, shown in red in Figure 2. This indicates that the health science community is becoming more acquaint to the issue of pragmatics. It is important to note that the majority of studies were conducted in primary care settings.