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

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

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The aim of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. They are usually requested by practitioners and policymakers to inform their decisions. They are also a good method of determining the cause-effect relationship between an intervention and its outcomes. However, they should not be used to replace explanatory studies.

The pragmatism idea is controversial, and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also suggested a framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a practical trial which includes the recruitment process, the design and implementation of the intervention, as well as monitoring.

There is a growing increase in the number pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs), yielded 34 articles, shown in red in Figure 2. This is an indication that the health science community is becoming more sensitive to the issue of pragmatic thinking. However, it is important to remember that the majority of these studies were conducted in primary care settings.