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Pragmatic trials are studies designed to inform real-world clinical practice. They are often focused on the practical aspects of study design, such as recruitment and consent in adherence, as well as the use of commonly available equipment.
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A pragmatic study that involves different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for a pragmatic trial to be reliable and to reduce bias in the results is also essential. However, too much heterogeneity can lead to problems with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually commissioned by practitioners and policy makers to inform their decision making. They can be used to determine the causality of an intervention and its effects. They should not, however, be used to replace the need for explanation studies.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials should be used to replace explanation tests or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the clinical or physiological hypothesis, and pragmatic trials, which inform the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study which includes the recruitment, design, and delivery of the intervention and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) produced 34 articles, shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. However, it is important to note that the majority of these trials were conducted in primary care settings.