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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often characterized as focusing on practical aspects of designing a study which include recruitment and consent, adherence and the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and included participants from different geographical regions. This type of heterogeneity that is crucial for a pragmatic trial to be valid and reduce bias in results, is also necessary. However excessive heterogeneity could result in problems with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically requested by practitioners and policymakers in order 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 to replace the need for explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they are an addition to them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which prove a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool sought to define the elements of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, and the follow-up.
There is a positive trend in the number of pragmatic trials published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the issue of pragmatism. It is important to note that the majority of these studies were conducted in primary-care settings.