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Pragmatic trials are those that are designed to inform real-world clinical practice. They are often characterized by their focus on practical aspects of design, including the recruitment process and consent, adhering and the use routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used different investigators and had participants from various geographical areas. This type of heterogeneity is necessary for practical trials to be valid and also reduces the chance of bias in the results. However, too much heterogeneity can lead to problems with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain maximum credibility externally. Usually, they are ordered by policymakers and practitioners in order to guide their decisions. They can be used to determine the cause-effect relationship of an intervention and its effects. They should, however, not, be used to replace explanation studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the validity of a clinical or physiological hypothesis as well as pragmatic trials, which inform the practice and policy decisions. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the elements of a pragmatic trial which includes recruitment, design and delivery of the intervention, and monitoring.
There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline query using the keywords 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 pragmatic thinking. It is important to keep in mind that the majority of these trials were conducted in primary care settings.
