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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically described by their focus on practical aspects of designing a study that include 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 various geographical regions 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. A high degree of heterogeneity, however can result in problems with the design of the trial.
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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually requested by policy makers and practitioners to guide their decision-making. They can be used to determine the causal relationship between an intervention with its outcomes. However, they should not, be used to replace the need for explanation studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they should serve as an alternative to them. Schwartz and Lellouch1 made the distinction between explanation studies, which support the physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the elements of a practical study that includes recruitment, design, implementation of the intervention, and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.