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Pragmatic trials are those that are designed to inform real-world clinical practice. They are usually focused on the practical aspects of study design, such as recruitment and consent as well as adherence to the use of routinely available equipment.
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A practical trial that employs different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for pragmatic trials to be valid and also helps reduce the chance of bias in the results. However, too much heterogeneity could cause issues with the design of the trial.
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The goal of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. They are usually commissioned by practitioners and policy makers to guide their decision-making. They can be used to determine the causality of an intervention with its outcomes. However, they should not be used as a substitute for the use of explanation studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can be used to replace explanation tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis, and pragmatic trials, which guide policy and practice decisions. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool attempted to define the features of a pragmatic study that include the recruitment process, the design and implementation of the intervention, and the follow-up.
There is a growing trend in the number of pragmatic trials that have been published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind, however, that the majority of these studies were conducted in primary care settings.