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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 often characterized by a focus on the practical aspects of research design, like recruitment and consent in adherence, as well as the use of standard equipment.

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A practical trial that employs different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. However, too much heterogeneity could cause issues with the design of the trial.

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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are usually commissioned by policy makers and practitioners to guide their decision-making. They can also be used to determine the causality of an intervention with its outcomes. They should, however, not be used to replace explanatory studies.

The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove a physiological or clinical hypothesis as well as pragmatic trials that inform the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic research study, including recruitment, design, delivery of the intervention, and follow-up.

The number of pragmatic trials is growing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This is an indication that the health science community is becoming more sensitive to the subject of pragmatism. It is important to remember that the majority of studies were conducted in primary-care settings.