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

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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographical regions. This kind of heterogeneity, that is crucial for pragmatic trials to be valid and reduce bias in results is also essential. However, too much heterogeneity could cause issues with the design of the trial.

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The aim of pragmatic trials is to replicate real-life scenarios and to achieve the highest level of validity externally. They are usually requested by practitioners and policy makers to inform their decision making. They can also be used to determine the causal relationship between an intervention and its effects. However, they should not be used as a substitute for the use of explanation trials.

The pragmatism concept is controversial, and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm a physiological or clinical hypothesis, and pragmatic trials that inform policy and practice decisions. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the characteristics of a pragmatic trial which includes the recruitment process, the design and implementation of the intervention, and the follow-up.

The number of pragmatic trials is growing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the subject of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.