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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often described by their focus on practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and included participants from different geographic areas. This kind of heterogeneity is required for pragmatic trials to be able to prove their validity and reduces the chance of bias in the results. Too much heterogeneity, however, can cause problems with the trial design.

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The aim of pragmatic trials is to mimic real-life situations and achieve maximum credibility externally. They are usually commissioned by policy makers and practitioners to inform their decision making. They also provide a useful method to determine the causal relationship between the 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 questions regarding whether pragmatic trials could replace tests for explanations or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the elements of a pragmatic trial that include the recruitment process, the design and implementation of the intervention, and the follow-up.

The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This indicates that the health science community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to keep in mind that the majority were conducted in primary-care settings.