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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically described by their focus on practical aspects of study design, including the recruitment process and consent, adhering and the use of routinely available 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 kind of heterogeneity is essential for pragmatic trials to be valid, and it also helps reduce the chance of bias in the results. However, too much heterogeneity can cause issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. Usually, they are ordered by policymakers and practitioners to inform their decisions. They can also be used to assess the causality of an intervention and its effects. They should not, however, be used to replace explanation studies.
The concept of pragmatism is controversial and there are concerns regarding whether pragmatic trials could be used to replace explanation tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate a physiological or clinical hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool attempted to define the features of a pragmatic trial, including recruitment, design and delivery of the intervention, as well as monitoring.
The number of pragmatic trials is growing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the issue of pragmatism. It is important to remember that the majority of these studies were conducted in primary care settings.