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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 focused on practical aspects of the study design, including recruitment and consent in adherence, as well as the use of routinely available equipment.

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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for pragmatic trials to be valid and to reduce bias in the results, is also necessary. However excessive heterogeneity could cause issues with the design of the trial.

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The aim of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are typically requested by practitioners and policymakers to guide their decisions. They can also be used to determine the causality of an intervention and its results. However, they should not, be used to replace explanatory studies.

The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 made a distinction between explanatory studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the decision-making process for policy and practice. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a practical study, including recruitment, design, implementation of the intervention and its follow-up.

There is a growing increase in the number pragmatic trials that have been published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs), yielded 34 articles, as shown in red in Figure 2. This is an indication that the health sciences community is becoming more sensitive to the issue of pragmatism. It is important to keep in mind that the majority of studies were conducted in primary-care settings.