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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often focused on practical aspects of the study design, such as the recruitment process and consent, adherence, and the use of routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and had participants from various geographical areas. This kind of heterogeneity is necessary for practical trials to be valid and helps to reduce bias in the results. However too much heterogeneity could cause issues with the design of the trial.

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The purpose of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. Usually, they are requested by practitioners and policymakers in order to inform their decisions. They can also be used to determine the causal relationship between an intervention and its results. However, they should not be used in lieu for explanation studies.

The pragmatism idea is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials that inform the practice and policy decisions. They also proposed the framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the features of a pragmatic study, including the recruitment process, the design and delivery of the intervention, and the follow-up.

There is an encouraging increase in the number of pragmatic trials published. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to remember that the majority of these trials were conducted in primary care settings.