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

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and participants from various geographical areas. This type of heterogeneity is required for pragmatic trials to be able to prove their validity, and it also helps reduce the chance of bias in the results. Too much heterogeneity, however can result in problems with the trial design.

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The purpose of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. Usually, they are requested by practitioners and policymakers to help inform their decisions. They also provide a useful method to determine the causality between an intervention and its results. However, they shouldn't be used in lieu for explanatory trials.

The pragmatism idea is controversial and there are doubts about whether pragmatic trials can be used to replace explanation tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool was designed to define the characteristics of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, as well as follow-up.

There is a growing trend in the number of pragmatic trials that are published. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on 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 that the majority of these trials were conducted in primary care settings.