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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are usually focused on the practical aspects of the study design, such as the recruitment process and consent, adherence, and the use of standard equipment.

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A pragmatic study that involves various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity, and it also helps reduce bias in the results. However, too much heterogeneity can lead to issues with the design of the trial.

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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 help guide their decisions. They can also be used to determine the causal relationship between an intervention and its effects. They should, however, not, be used to replace the need for explanation studies.

The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove a physiological or clinical hypothesis, and pragmatic trials that inform the practice and policy decisions. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool was designed to define the features of a practical trial, including the recruitment process, the design and delivery of the intervention, and monitoring.

There is a positive trend in the number of pragmatic trials published. A recent Medline query using the keywords 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 is becoming more aware of the importance of pragmatic thinking. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.