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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are often characterized by their focus on practical aspects of design which include the recruitment process and consent, adhering and the use routinely available equipment.
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A pragmatic trial that uses different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for pragmatic trials to be valid, and it also reduces bias in the results. However excessive heterogeneity could result in issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. They are usually commissioned by policymakers and practitioners in order to guide their decisions. They can also be used to assess the causality of an intervention and its effects. They should, however, not, be used to replace explanation studies.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the validity of a clinical or physiological hypothesis and pragmatic trials, which inform the practice and policy decisions. They also suggested the framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the elements of a pragmatic study that include the recruitment process, the design and
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There is an encouraging increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health science community is becoming more acquaint to the subject of pragmatism. It is important to note that the majority of these studies were conducted in primary care settings.