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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized as focusing on practical aspects of designing a study, including recruitment and consent, adherence and the use of routinely available equipment.

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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and had participants from different geographic areas. This kind of heterogeneity is required for pragmatic trials to be able to prove their validity and helps to reduce bias in the results. However too much heterogeneity could result in problems with the design of the trial.

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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually commissioned by policymakers and practitioners to inform their decisions. They can be used to determine the causal relationship between an intervention and its results. They should not, however, be used to replace explanation studies.

The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they should be an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the practice and policy decision-making. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a practical trial that include the recruitment process, the design and delivery of the intervention, and monitoring.

There is a growing increase in the number of pragmatic trials that are published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) resulted in 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the issue of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.