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Pragmatic trials are studies designed to provide information for the real-world practice of clinical. They are usually focused on the practical aspects of study design, such as the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and had participants from different geographical regions. This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and also reduces the chance of bias in the results. A high degree of heterogeneity, however could cause issues with the design of the trial.
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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually ordered by policymakers and practitioners in order to inform their decisions. They can be used to determine the causality of an intervention and its effects. However, they shouldn't be used in lieu for explanatory trials.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should be used to replace explanation tests or if they are an addition to them. Schwartz and Lellouch1 made the distinction between explanation studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool sought to define the elements of a pragmatic trial that include recruitment, design and delivery of the intervention, as well as monitoring.
The number of pragmatic trials is increasing. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the subject of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary care settings.