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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically described as focusing on practical aspects of design, including recruitment and consent, adherence and the use of routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and had participants from various geographical areas. This type of heterogeneity is essential for practical trials to be valid and reduces bias in the results. However excessive heterogeneity could cause problems with the design of the trial.

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The aim of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. They are typically commissioned by policy makers and practitioners to guide their decision-making. They can also be used to determine the causal relationship between an intervention with its outcomes. However, they shouldn't be used in lieu 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 a complement to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a practical study, including recruitment, design, delivery of the intervention, and follow-up.

There is a positive increase in the number of pragmatic trials that are published. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health science community is becoming more acquaint to the issue of pragmatics. It is important to remember, however, that the majority of these studies were conducted in primary-care settings.