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Pragmatic trials are trials designed to provide information for the real-world practice of clinical. They are typically described by their focus on practical aspects of design, including 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 various investigators and had participants from different geographical regions. This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity and reduces the chance of bias in the results. However too much heterogeneity could lead to problems with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. They are usually requested by practitioners and policy makers to aid in their decision-making. They can be used to determine the causality of an intervention and its effects. They should, however, not be used to replace explanatory studies.
The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool sought to define the features of a pragmatic trial that include recruitment, design and delivery of the intervention, and follow-up.
There is a positive trend in the number of pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to remember that the majority of these trials were conducted in primary care settings.