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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often characterized by their focus on practical aspects of design that include the recruitment process and consent, adhering and the use of routinely available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and had participants from different geographical regions. This type of heterogeneity, which is essential for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. However excessive heterogeneity could result in problems with the design of the trial.

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The purpose of pragmatic trials is to simulate real-life scenarios and to achieve maximum validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can also be used to determine the causality of an intervention and its results. However, they shouldn't be used as a substitute for explanatory trials.

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

The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited 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 trials were conducted in primary care settings.