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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are usually focused on practical aspects of the study design, such as recruitment and consent, adherence, and the use of standard equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and participants from different geographic areas. This type of heterogeneity is required for practical trials to be valid and helps reduce bias in the results. Too much heterogeneity, however can result in problems with the design of the trial.

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The goal of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. Usually, they are ordered by policymakers and practitioners in order to inform their decisions. They can be used to determine the causal relationship between an intervention and its effects. They should, however, not be used to replace explanatory studies.

The pragmatism concept is controversial, and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement 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 suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the elements of a pragmatic trial which includes the recruitment process, the design and delivery of the intervention, and the follow-up.

The number of pragmatic trials is growing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs), yielded 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 pragmatic thinking. It is important to keep in mind that the majority of these trials were conducted in primary care settings.