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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically described as a focus on the practical aspects of study design that include the recruitment process and consent, adhering and the use of routinely available equipment.
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A practical trial that employs various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for pragmatic trials to be valid and lessen the chance of bias, is also necessary. However excessive heterogeneity could result in issues with the design of the trial.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are typically commissioned by policymakers and practitioners to guide their decisions. They can also be a great method of determining the causal relationship between the intervention and its effects. However, they should not be used in lieu for explanatory trials.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which prove a physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the practice and policy decision-making. They also proposed the framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the elements of a pragmatic study which includes the recruitment process, the design and implementation of the intervention, as well as monitoring.
The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, limited to randomized controlled trials (RCTs) produced 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the issue of pragmatic thinking. It is important to remember, however, that the majority of studies were conducted in primary-care settings.