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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often described as a focus on the practical aspects of designing a study that include the recruitment and consent process, as well as adherence and the use of routinely available equipment.

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A pragmatic study that involves a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for pragmatic trials to be reliable and to reduce bias in the results is also essential. However too much heterogeneity could result in issues with the design of the trial.

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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually requested by practitioners and policymakers to help inform their decisions. They can 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 questions about whether pragmatic trials can be used to replace explanation tests or if they are an alternative to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials, which inform policy and practice decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic study which includes recruitment, design, implementation of the intervention and its follow-up.

There is an encouraging increase in the number 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 shown in red on Figure 2. This is an indication that the health sciences 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.