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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically focused on the practical aspects of study design, including the recruitment and consent process in adherence, as well as the use of standard equipment.
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A pragmatic study that involves various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for pragmatic trials to be able to prove their validity and helps reduce bias in the results. However excessive heterogeneity could lead to problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. They are typically commissioned by policymakers and practitioners in order to guide their decisions. They can be used to determine the causality of an intervention and its effects. However, they should not be used to replace the need for explanation studies.
The pragmatism concept 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 confirm the clinical or physiological hypothesis, and pragmatic trials, which inform the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic study that includes the recruitment, design, and delivery of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline search using 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 has become more aware of the importance of pragmatism. It is important to keep in mind that the majority of studies were conducted in primary-care settings.