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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 focused on practical aspects of the study design, including the recruitment and consent process, adherence, and the use of commonly available equipment.

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A pragmatic study that involves different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for a pragmatic trial to be reliable and to reduce bias in the results, is also necessary. However, too much heterogeneity can result in issues with the design of the trial.

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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They also provide a useful way to identify the causality between an intervention and its results. They should not, however, be used to replace the need for explanation studies.

The idea of pragmatism is controversial, and there are questions regarding whether pragmatic trials could be used to replace explanation tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials that aid in the decision-making process for policy and practice. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic research study which includes the recruitment, design, and delivery of the intervention and follow-up.

The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to keep in mind that the majority were conducted in primary-care settings.