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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 characterized by a focus on practical aspects of the study design, including recruitment and consent as well as adherence to the use of standard 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 is necessary for pragmatic trials to be able to prove their validity and helps to reduce the chance of bias in the results. However, too much heterogeneity can result in problems with the trial design.

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The aim of pragmatic trials is to mimic real-life scenarios and to achieve maximum validity externally. They are typically commissioned by practitioners and policy makers to aid in their decision-making. They can be used to determine the causal relationship between an intervention and its results. However, they should not be used to replace explanation studies.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should replace tests for explanations or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis and pragmatic trials, which inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the traits of a practical study that includes the recruitment, design, and delivery of the intervention, and follow-up.

There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) produced 34 articles, as shown in red in Figure 2. This is a sign that the health sciences community is becoming increasingly sensitized to the subject of pragmatics. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.