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

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and participants from different geographic areas. This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity, and it also reduces the chance of bias in the results. However, too much heterogeneity could cause issues with the design of the trial.

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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually ordered by policymakers and practitioners to inform their decisions. They also provide a useful method of determining the causal relationship between the intervention and its effects. However, they should not be used to replace explanation studies.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials can be used to replace explanation tests or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis and pragmatic trials, which inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the traits of a practical study, including recruitment, design, delivery of the intervention and its follow-up.

There is a growing increase in the number pragmatic trials that are published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) resulted in 34 articles, shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to remember that the majority of these trials were conducted in primary care settings.