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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often described as a focus on the practical aspects of study design, including the recruitment process and consent, adhering 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 used a variety of investigators and participants from different geographic areas. This kind of heterogeneity, which is essential for a pragmatic trial to be valid and reduce bias in results, is also necessary. However too much heterogeneity could lead to issues with the design of the trial.

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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually requested by policy makers and practitioners to guide their decision-making. They also provide a useful method of determining the cause-effect relationship between an intervention and its outcomes. However, they should not be used as a substitute for the use of explanation trials.

The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which confirm the validity of a physiological or clinical hypothesis, and pragmatic trials that aid in the decision-making process for policy and practice. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a pragmatic study which includes recruitment, design and delivery of the intervention, as well as monitoring.

There is a growing trend in the number of pragmatic trials published. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health science community is becoming more sensitive to the subject of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary care settings.