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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are often characterized by a focus on the practical aspects of the research design, like recruitment and consent, adherence, 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 various investigators and included participants from different geographical regions. This type of heterogeneity is essential for pragmatic trials to be valid, and it also helps to reduce bias in the results. A high degree of heterogeneity, however, can cause problems with the design of the trial.

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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are typically commissioned by policymakers and practitioners to help guide their decisions. They can also be used to assess the cause-effect relationship of an intervention and its results. However, they should not, be used to replace the need for explanation studies.

The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the traits of a practical study that includes the recruitment, design, and delivery of the intervention and follow-up.

There is a positive trend in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This is a sign that the health science community is becoming more acquaint to the subject of pragmatics. It is important to note that the majority of studies were conducted in primary care settings.