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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often described as a focus on the practical aspects of design, including recruitment and consent, adherence and the use routinely available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and participants from various geographical areas. This type of heterogeneity, which is vital for a pragmatic trial to be valid and reduce bias in results is also essential. However, too much heterogeneity can lead to issues with the design of the trial.

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The goal of pragmatic trials is to mimic real-life situations and achieve maximum validity externally. They are typically commissioned by policy makers and practitioners to inform their decision making. They also provide a useful way to identify the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used in lieu for the use of explanation trials.

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 a distinction between explanatory studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the characteristics of a pragmatic trial, including the recruitment process, the design and implementation of the intervention, as well as monitoring.

There is a positive 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), yielded 34 articles, as shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to keep in mind, however, that the majority were conducted in primary-care settings.