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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically described by their focus on practical aspects of study design which include recruitment and consent, adherence and the use routinely available equipment.

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

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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. They are typically commissioned by practitioners and policy makers to guide their decision-making. They are also a good method of determining the causality between an intervention and its results. However, they shouldn't be used as a substitute for explanatory studies.

The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they should be an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm a physiological or clinical hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also proposed the framework for pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a practical trial, including the recruitment process, the design and implementation of the intervention, and monitoring.

There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs) produced 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary-care settings.