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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often characterized by a focus on practical aspects of the study design, such as the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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A pragmatic trial that uses a variety investigators and includes 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 reliable and to reduce bias in the results, is also necessary. However, too much heterogeneity, can cause problems with the trial design.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are usually ordered by policymakers and practitioners to help inform their decisions. They can also be used to assess the causality of an intervention and its effects. They should, however, not be used to replace explanatory studies.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove a physiological or clinical hypothesis as well as pragmatic trials that inform policy and practice decisions. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the elements of a practical trial that include the recruitment process, the design and implementation of the intervention, as well as follow-up.
The number of pragmatic trials is growing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health science community is becoming more acquaint to the issue of pragmatics. It is important to keep in mind that the majority were conducted in primary care settings.