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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often focused on the practical aspects of study design, including recruitment and consent in adherence, as well as the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed various investigators and included participants from various geographical areas. This type of heterogeneity which is essential for pragmatic trials to be reliable and reduce bias in results, is also necessary. However, too much heterogeneity could cause issues with the design of the trial.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. Usually, they are ordered by policymakers and practitioners to help inform their decisions. They also provide a useful way to identify the causal relationship between an intervention and its outcomes. They should not, however be used to replace the need for explanation studies.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also proposed the framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, and follow-up.
There is a growing increase in the number of pragmatic trials that are published. A recent Medline search using the keywords 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 sensitive to the subject of pragmatic thinking. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.