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Pragmatic trials are studies designed to provide information for the practice of clinical trials in real life. They are often described as focusing on practical aspects of design that include the recruitment process and consent, adhering and the use 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 type of heterogeneity which is vital for pragmatic trials to be reliable and reduce bias in results is also essential. However, too much heterogeneity can result in problems with the trial design.
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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 to inform their decisions. They also provide a useful method to determine the causal relationship between an intervention and its results. They should, however, not be used to replace explanation studies.
The pragmatism idea is controversial, and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials, which guide policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic study which includes recruitment, design, implementation of the intervention and follow-up.
There is a positive increase in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the subject of pragmatics. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.