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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically characterized by a focus on practical aspects of the research design, like recruitment and consent in adherence, as well as the use of routinely available equipment.

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A practical trial that employs 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 valid and to reduce bias in the results is also essential. A high degree of heterogeneity, however, can cause problems with the trial design.

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The goal of pragmatic trials is to simulate real-life scenarios and to achieve maximum credibility externally. They are usually commissioned by policymakers and practitioners in order to inform their decisions. They also provide a useful method of determining the cause-effect relationship between an intervention and its outcomes. However, they should not be used to substitute for explanatory trials.

The idea of pragmatism is controversial and there are concerns regarding whether pragmatic trials could be used to replace explanation tests or if they should serve as a complement to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform the decision-making process for policy and practice. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool attempted to define the characteristics of a pragmatic trial which includes recruitment, design and delivery of the intervention, as well as the follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) resulted in 34 articles, shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.