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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 characterized by a focus on practical aspects of the research design, like the recruitment and consent process, adherence, and the use of routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and had participants from different geographic areas. This kind of heterogeneity, which is vital for a pragmatic trial to be valid and reduce bias in results, is also necessary. However, too much heterogeneity could cause issues with the trial design.

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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They can also be used to assess the causality of an intervention with its outcomes. They should not, however, be used to replace explanatory studies.

The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace tests for explanations or if they should be a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove a physiological or clinical hypothesis and pragmatic trials, which guide policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic study, including recruitment, design, delivery of the intervention and its follow-up.

There is a growing trend in the number of pragmatic trials that have been published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the issue of pragmatism. It is important to keep in mind that the majority of these trials were conducted in primary care settings.