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Pragmatic trials are trials designed to provide information for real-world clinical practice. They are often described by their focus on practical aspects of designing a study which include the recruitment process and consent, adhering and the use of standard equipment.
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A pragmatic study that involves various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be valid and also reduces the chance of bias in the results. However excessive heterogeneity could cause problems with the design of the trial.
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Legality
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The goal of pragmatic trials is to replicate real-life scenarios and gain the highest level of validity externally. Usually, they are requested by practitioners and policymakers to help guide their decisions. They also provide a useful method to determine the cause-effect relationship between an intervention and its results. However, they should not be used in lieu for explanatory studies.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool was designed to define the elements of a pragmatic trial, including the recruitment process, the design and implementation of the intervention, and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) resulted in 34 articles, 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 studies were conducted in primary care settings.