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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are usually 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 a variety investigators and includes participants from various geographical regions 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 helps reduce bias in the results. A high degree of heterogeneity, however could cause issues with the design of the trial.

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The goal of pragmatic trials is to mimic real-life scenarios and to achieve the highest level of validity externally. They are usually requested by practitioners and policy makers to inform their decision making. They can also be a great method of determining the cause-effect relationship between the intervention and its effects. They should not, however, be used to replace the need for explanation studies.

The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace explanatory tests or if they should be a complement 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 the decision-making process for policy and practice. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool was designed to define the features of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, as well as follow-up.

There is a positive increase in the number pragmatic trials that are published. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind that the majority of studies were conducted in primary-care settings.