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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often described as a focus on the practical aspects of designing a study which include the recruitment and consent process, as well as adherence and the use of routinely available equipment.

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

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The purpose of pragmatic trials is to mimic real-life scenarios and to achieve maximum validity externally. They are usually requested by policy makers and practitioners to guide their decision-making. They can also be used to assess the cause-effect relationship of an intervention and its results. However, they shouldn't be used to substitute for the use of explanation 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 validate the validity of a clinical or physiological hypothesis and pragmatic trials that inform the practice and policy decisions. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a pragmatic study, including recruitment, design and delivery of the intervention, as well as the follow-up.

There is a positive increase in the number pragmatic trials that have been published. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the issue of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.