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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often focused on the practical aspects of study design, including the recruitment and consent process as well as adherence to the use of commonly available equipment.

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A pragmatic study that involves various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and also helps to reduce the chance of bias in the results. Too much heterogeneity, however could cause issues with the trial design.

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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are typically requested by practitioners and policymakers to guide their decisions. They are also a good way to identify the cause-effect relationship between an intervention and its results. However, they should not be used to substitute for the use of explanation trials.

The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could be used to replace explanation tests or if they are an alternative to them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which prove the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also suggested a framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the features of a pragmatic study which includes the recruitment process, the design and implementation of the intervention, and the follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs), yielded 34 articles, shown in red in Figure 2. This is a sign that the health sciences 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.