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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often characterized as a focus on the practical aspects of study design that include the recruitment and consent process, as well as adherence and the use of standard equipment.

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A practical trial that employs a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for practical trials to be valid and also helps to reduce the chance of bias in the results. However, too much heterogeneity can result in issues with the design of the trial.

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The aim of pragmatic trials is to replicate real-life scenarios and gain the highest level of validity externally. They are typically requested by practitioners and policymakers in order to inform their decisions. They are also a good method to determine the cause-effect relationship between the 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 an distinction between explanation-based 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 called PRECIS for pragmatic trials.2 This tool attempted to define the traits of a practical study that includes recruitment, design, delivery of the intervention and its follow-up.

There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) resulted in 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more sensitive to the issue of pragmatic thinking. It is important to remember, however, that the majority of these studies were conducted in primary care settings.