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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are typically described by their focus on practical aspects of designing a study which include the recruitment process and consent, adhering and the use of routinely available equipment.

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A pragmatic study that involves various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for pragmatic trials to be valid and also reduces the chance of bias in the results. However, too much heterogeneity can cause issues with the design of the trial.

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The purpose of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. They are usually commissioned by policymakers and practitioners to help guide their decisions. They can also be a great way to identify the cause-effect relationship between the intervention and its effects. They should, however, not, be used to replace the need for explanation studies.

The pragmatism idea is controversial, and there are questions regarding whether pragmatic trials could replace explanatory tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm a physiological or clinical hypothesis as well as pragmatic trials, which inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic study, including recruitment, design, delivery of the intervention, and follow-up.

The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the issue of pragmatic thinking. It is important to remember, however, that the majority of these studies were conducted in primary care settings.