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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 as a focus on the practical aspects of designing a study which include recruitment and consent, adherence and the use routinely available equipment.

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

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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are typically commissioned by policymakers and practitioners in order to guide their decisions. They can also be used to determine the causality of an intervention with its outcomes. However, they should not be used to substitute for explanatory trials.

The concept of pragmatism is controversial and there are concerns about whether pragmatic trials can be used to replace explanation tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis, and pragmatic trials that inform the policy and practice of. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a pragmatic study which includes recruitment, design and delivery of the intervention, as well as monitoring.

There is an encouraging trend in the number of pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to remember that the majority of these studies were conducted in primary care settings.