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Pragmatic trials are those that are designed to inform the real-world practice of clinical. They are often described as focusing on practical aspects of study design, including the recruitment and consent process, as well as adherence and the use of routinely available 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 kind of heterogeneity is necessary for pragmatic trials to be valid and also reduces bias in the results. However, too much heterogeneity can cause issues with the design of the trial.

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The aim of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are usually ordered by policymakers and practitioners to guide their decisions. They can also be a great method to determine the causality between the intervention and its effects. However, they should not be used in lieu for explanation trials.

The pragmatism concept is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which confirm the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the characteristics of a pragmatic study, including the recruitment process, the design and implementation of the intervention, as well as the follow-up.

There is a positive trend in the number of pragmatic trials that are published. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatics. However, it is important to remember that the majority of these studies were conducted in primary care settings.