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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically described by their focus on practical aspects of study design that include the recruitment and consent process, as well as adherence and the use routinely available equipment.
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A pragmatic trial that uses various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for practical trials to be valid and also helps to reduce bias in the results. Too much heterogeneity, however, can cause 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 usually requested by policy makers and practitioners to aid in their decision-making. They can also be a great method to determine the causal relationship between an intervention and its results. However, they should not, be used to replace explanation studies.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation 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 This tool tried to define the traits of a pragmatic study, including the recruitment, design, and delivery of the intervention, and follow-up.
There is a growing increase 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 suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note, however, that the majority of studies were conducted in primary care settings.