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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized by a focus on practical aspects of the study design, including the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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A pragmatic trial that uses various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for pragmatic trials to be valid and reduces 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-world situations and have the highest external validity. They are typically commissioned by policymakers and practitioners to guide their decisions. They can be used to determine the causality of an intervention with its outcomes. However, they should not be used to substitute for explanatory studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis as well as pragmatic trials, which inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic study which includes recruitment, design, implementation of the intervention and follow-up.
There is a positive increase in the number pragmatic trials published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) resulted in 34 articles, as shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind that the majority of these trials were conducted in primary care settings.