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Pragmatic trials are trials designed to inform the real-world practice of clinical. They are often characterized by their focus on practical aspects of study design which include the recruitment and consent process, as well as adherence and the use of standard equipment.
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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, that is crucial for a pragmatic trial to be reliable and to reduce bias in the results is also essential. However too much heterogeneity could cause 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 typically ordered by policymakers and practitioners to help inform their decisions. They can also be used to determine the causal relationship between an intervention and its results. However, they should not be used to substitute for explanatory studies.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials, which inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study that includes recruitment, design, implementation of the intervention, and follow-up.
There is an encouraging trend in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.