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Pragmatic trials are studies designed to inform the practice of clinical trials in real life. They are usually focused on practical aspects of the research design, like the recruitment and consent process in adherence, as well as the use of commonly available equipment.

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A pragmatic trial that uses different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is vital for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. However too much heterogeneity could result in issues with the design of the trial.

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The aim of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. They are usually commissioned by practitioners and policy makers to inform their decision making. They are also a good way to identify the causality between an intervention and its results. However, they shouldn't be used to substitute for the use of explanation studies.

The pragmatism idea is controversial and there are concerns regarding whether pragmatic trials could replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the characteristics of a pragmatic study which includes the recruitment process, the design and implementation of the intervention, and monitoring.

There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more acquaint to the issue of pragmatics. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.