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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are typically described as a focus on the practical aspects of designing a study which include the recruitment and consent process, as well as adherence and the use routinely available equipment.

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A pragmatic study that involves a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for pragmatic trials to be valid, and it also helps to reduce the chance of bias in the results. However excessive heterogeneity could cause problems with the design of the trial.

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The goal of pragmatic trials is to mimic real-life scenarios and to achieve the highest level of validity externally. Usually, they are ordered by policymakers and practitioners to guide their decisions. They can also be used to assess the cause-effect relationship of an intervention and its effects. They should not, however be used to replace the need for explanation studies.

The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace explanatory tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic study that includes recruitment, design, implementation of the intervention, and follow-up.

There is a growing increase in the number of pragmatic trials that have been published. A recent Medline search using the words pragmatic and naturalistic, limited 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 increasingly sensitized to the issue of pragmatic thinking. It is important to note that the majority of these trials were conducted in primary care settings.