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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often characterized by their focus on practical aspects of designing a study that include the recruitment process and consent, adhering and the use routinely available 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 pragmatic trials to be reliable and to reduce bias in the results, is also necessary. Too much heterogeneity, however, can cause problems with the trial design.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are typically ordered by policymakers and practitioners in order to inform their decisions. They can also be a great method to determine the causality between an intervention and its results. However, they should not be used as a substitute for the use of explanation trials.
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 made the distinction between explanation studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a pragmatic research study that includes the recruitment, design, and delivery of the intervention and its follow-up.
There is an encouraging increase in the number of pragmatic trials published. A recent Medline query that used the words pragmatic and naturalistic, limited 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 pragmatic thinking. It is important to remember, however, that the majority of these studies were conducted in primary care settings.