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Pragmatic trials are studies designed to provide information for real-world clinical practice. They are often characterized by a focus on the practical aspects of study design, such as the recruitment process and consent in adherence, as well as the use of routinely available equipment.

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A practical trial that employs a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for practical trials to be valid and helps reduce the chance of bias in the results. A high degree of heterogeneity, however could cause issues with the design of the trial.

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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are usually requested by policy makers and practitioners to guide their decision-making. They are also a good method to determine the cause-effect relationship between an intervention and its outcomes. They should not, however, be used to replace the need for explanation studies.

The pragmatism idea is controversial and there are concerns regarding whether pragmatic trials could be used to replace explanation tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm a physiological or clinical hypothesis and pragmatic trials that inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic research study, including the recruitment, design, and delivery of the intervention and follow-up.

There is a positive increase in the number pragmatic trials published. A recent Medline search using 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 is a sign that the health science community is becoming more acquaint to the issue of pragmatics. However, it is important to remember that the majority of these trials were conducted in primary care settings.