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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are usually focused on practical aspects of the study design, such as recruitment and consent as well as adherence to the use of routinely available equipment.
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A practical trial that employs different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity that is crucial for pragmatic trials to be reliable and reduce bias in results is also essential. A high degree of heterogeneity, however can result in problems with the trial design.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually requested by policy makers and practitioners to guide their decision-making. They are also a good way to identify the causal relationship between an intervention and its outcomes. They should, however, not be used to replace explanation studies.
The pragmatism idea is controversial and there are doubts 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 guide the practice and policy decisions. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the elements of a practical trial which includes the recruitment process, the design and implementation of the intervention, as well as the 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. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.