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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often described by their focus on practical aspects of designing a study which include the recruitment and consent process, as well as adherence and the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and included participants from various geographical areas. This type of heterogeneity, which is vital for pragmatic trials to be valid and lessen the chance of bias, is also necessary. However, too much heterogeneity can result in problems with the trial design.
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The purpose of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. They are usually ordered by policymakers and practitioners to help inform their decisions. They are also a good method to determine the cause-effect relationship between an intervention and its outcomes. They should, however, not, be used to replace explanation studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials should replace explanatory tests or if they should be an addition to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials, which inform policy and practice decisions. They also suggested an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a pragmatic study, including recruitment, design and delivery of the intervention, and follow-up.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind, however, that the majority of studies were conducted in primary-care settings.