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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often described as focusing on practical aspects of study design which include recruitment and consent, adherence and the use of routinely available equipment.

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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for pragmatic trials to be valid and also helps reduce the chance of bias in the results. However, too much heterogeneity can 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 typically commissioned by policymakers and practitioners to help inform their decisions. They are also a good method to determine the causal relationship between the intervention and its effects. However, they should not be used in lieu for the use of explanation studies.

The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove a physiological or clinical hypothesis and pragmatic trials, which inform policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic study which includes recruitment, design, implementation of the intervention and follow-up.

The number of pragmatic trials is growing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the issue of pragmatic thinking. It is important to remember that the majority of studies were conducted in primary-care settings.