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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on the practical aspects of study design, including recruitment and consent as well as adherence to the use of routinely available equipment.

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A practical trial that employs various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, that is crucial for pragmatic trials to be reliable and lessen the chance of bias is also essential. However, too much heterogeneity can cause issues with the design of the trial.

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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are typically commissioned by practitioners and policy makers to inform their decision making. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. They should not, however, be used to replace explanatory studies.

The concept of pragmatism is controversial and there are concerns about whether pragmatic trials can replace tests for explanations or if they should serve as an alternative to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. 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 of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs), yielded 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to remember that the majority of these trials were conducted in primary care settings.

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