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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 by a focus on practical aspects of the study design, including the recruitment process and consent, adherence, and the use of commonly available equipment.

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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for pragmatic trials to be reliable and reduce bias in results is also essential. 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. Usually, they are requested by practitioners and policymakers to help inform their decisions. They are also a good method to determine the cause-effect relationship between an intervention and its results. However, they should not, be used to replace the need for explanation studies.

The idea of pragmatism is controversial, and there are questions about whether pragmatic trials can replace tests for explanations or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the validity of a clinical or physiological hypothesis, and pragmatic trials, which inform the practice and policy decisions. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the elements of a practical trial which includes recruitment, design and delivery of the intervention, and follow-up.

There is an encouraging increase in the number pragmatic trials that are published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these studies were conducted in primary care settings.