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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are often described by their focus on practical aspects of designing a study, including recruitment and consent, adherence and the use of routinely available equipment.

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A pragmatic study that involves different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is vital for a pragmatic trial to be valid and to reduce bias in the results is also essential. However too much heterogeneity could cause problems with the design of the trial.

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The goal of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. They are usually commissioned by practitioners and policy makers to inform their decision making. They can also be a great method of determining the causality between an intervention and its outcomes. However, they should not be used as a substitute for explanation trials.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials can replace explanatory tests or if they are an addition to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis and pragmatic trials, which guide policy and practice decisions. They also suggested an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a practical trial, including the recruitment process, the design and implementation of the intervention, and monitoring.

The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more acquaint to the subject of pragmatism. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.