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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 their focus on practical aspects of study design that include the recruitment and consent process, as well as adherence and 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 utilized various investigators and had participants from various geographical areas. This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also reduces bias in the results. Too much heterogeneity, however could cause issues with the design of the trial.

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The goal of pragmatic trials is to simulate real-life situations and achieve the highest level of validity externally. Usually, they are requested by practitioners and policymakers in order to guide their decisions. They are also a good method of determining the causality between an intervention and its outcomes. They should, however, not be used to replace the need for explanation studies.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials can replace tests for explanations or if they should serve as an addition to them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the characteristics of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, as well as monitoring.

There is an encouraging trend in the number of pragmatic trials that are published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the issue of pragmatics. It is important to remember that the majority were conducted in primary-care settings.