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

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed different investigators and participants from different geographical regions. This kind of heterogeneity, that is crucial for a pragmatic trial to be valid and reduce bias in results, is also necessary. However, too much heterogeneity can result in problems with the trial design.

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The aim of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. They are usually commissioned by practitioners and policy makers to guide their decision-making. They can also be used to determine the causal relationship between an intervention and its results. However, they should not be used to replace explanatory studies.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a practical trial, including the recruitment process, the design and delivery of the intervention, and follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the subject of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.