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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are often described by their focus on practical aspects of designing a study which include recruitment and consent, adherence and the use of standard equipment.
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A pragmatic study that involves different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also reduces the chance of bias in the results. Too much heterogeneity, however, can cause problems with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life scenarios and gain the highest level of validity externally. They are usually commissioned by policymakers and practitioners to help inform their decisions. They can also be a great method to determine the cause-effect relationship between an intervention and its results. They should not, however, be used to replace explanation studies.
The pragmatism concept is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic study that includes recruitment, design, implementation of the intervention and follow-up.
There is a growing trend in the number of pragmatic trials that have been published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.