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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically characterized by a focus on the practical aspects of study design, such as the recruitment process and consent in adherence, as well as the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and included participants from different geographic areas. This type of heterogeneity that is crucial for a pragmatic trial to be valid and lessen the chance of bias, is also necessary. However, too much heterogeneity could cause issues with the design of the trial.

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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are typically requested by practitioners and policymakers in order to inform their decisions. They are also a good way to identify the causality between an intervention and its results. They should, however, not, be used to replace explanatory 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 the distinction between explanatory trials, which validate a physiological or clinical hypothesis and pragmatic trials, which inform the practice and policy decisions. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool was designed to define the features of a pragmatic study that include the recruitment process, the design and implementation of the intervention, as well as follow-up.

The number of pragmatic trials is growing. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health science community is becoming more acquaint to the issue of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary-care settings.