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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described as a focus on the practical aspects of study design that include recruitment and consent, adherence and the use routinely available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and included participants from different geographic areas. This type of heterogeneity that is crucial for pragmatic trials to be valid and reduce bias in results is also essential. Too much heterogeneity, however could cause issues with the design of the trial.

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The aim of pragmatic trials is to replicate real-life situations and achieve maximum credibility externally. They are typically commissioned by practitioners and policy makers to inform their decision making. They are also a good method to determine the cause-effect relationship between an intervention and its results. They should not, however be used to replace explanatory studies.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made a distinction between explanatory studies, which prove a physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool attempted to define the features of a pragmatic study, including recruitment, design and delivery of the intervention, and the follow-up.

There is a positive increase in the number pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs) resulted in 34 articles, shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.