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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are typically described by their focus on practical aspects of designing a study which include the recruitment process and consent, adhering 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 employed various investigators and included participants from different geographical regions. This type of heterogeneity that is crucial for a pragmatic trial to be reliable and reduce bias in results is also essential. A high degree of heterogeneity, however could cause issues with the trial design.

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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. Usually, they are ordered by policymakers and practitioners to help inform their decisions. They are also a good method of determining the cause-effect relationship between the intervention and its effects. They should not, however, be used to replace explanatory studies.

The pragmatism idea is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the practice and policy decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic study which includes recruitment, design, delivery of the intervention and its follow-up.

There is an encouraging increase in the number of pragmatic trials that have been 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 is a sign that the health science community is becoming more acquaint to the issue of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary-care settings.