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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized by their focus on practical aspects of design which include the recruitment and consent process, as well as 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 used a variety of investigators and had participants from various geographical areas. This type of heterogeneity which is essential for a pragmatic trial to be valid and to reduce bias in the results is also essential. However too much heterogeneity could cause issues with the design of the trial.

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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. Usually, they are requested by practitioners and policymakers in order to guide their decisions. They can also be used to determine the cause-effect relationship of an intervention and its effects. However, they should not be used to substitute for explanatory trials.

The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the clinical or physiological hypothesis and pragmatic trials, which guide the policy and practice of. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the features of a practical trial that include recruitment, design and delivery of the intervention, as well as monitoring.

The number of pragmatic trials is growing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This is an indication that the health science community is becoming more acquaint to the subject of pragmatism. It is important to note, however, that the majority were conducted in primary-care settings.