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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are usually characterized by a focus on the practical aspects of the research design, like the recruitment and consent process in adherence, as well as the use of commonly available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and included participants from various geographical areas. This type of heterogeneity is essential for pragmatic trials to be able to prove their validity and reduces the chance of bias in the results. Too much heterogeneity, however, can cause problems with the trial design.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are usually requested by practitioners and policymakers in order to inform their decisions. They can also be used to assess the causality of an intervention and its results. However, they shouldn't be used to substitute for explanatory studies.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the practice and policy decision-making. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool sought to define the elements of a pragmatic study, including the recruitment process, the design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is increasing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health sciences community is becoming increasingly sensitized to the issue of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.