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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are usually characterized by a focus on the practical aspects of research design, like the recruitment process and consent, adherence, and the use of standard 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 necessary for pragmatic trials to be valid and also helps to reduce bias in the results. However, too much heterogeneity can cause problems with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. Usually, they are ordered by policymakers and practitioners to inform their decisions. They can also be used to assess the causal relationship between an intervention with its outcomes. They should not, however be used to replace the need for 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 explanatory trials, which prove a physiological or clinical 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 characteristics of a practical trial that include recruitment, design and delivery of the intervention, as well as the follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs), yielded 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note that the majority of studies were conducted in primary care settings.