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Pragmatic trials are studies designed to inform the real-world practice of clinical. They are often characterized by their focus on practical aspects of design that include the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and included participants from different geographical regions. This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also helps to reduce bias in the results. However too much heterogeneity could lead to problems with the design of the trial.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. Usually, they are commissioned by policymakers and practitioners to help guide their decisions. They are also a good method to determine the causal relationship between an intervention and its outcomes. However, they should not be used to replace explanation studies.
The pragmatism concept is controversial, and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis and pragmatic trials, which guide the practice and policy decisions. They also proposed the framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the features of a practical trial, including recruitment, design and delivery of the intervention, and the follow-up.
There is an encouraging increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority of studies were conducted in primary care settings.
