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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are typically described by their focus on practical aspects of designing a study that include the recruitment and consent process, as well as 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 used different investigators and had participants from various geographical areas. This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and also helps to reduce bias in the results. However, too much heterogeneity can result in problems with the trial design.
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The goal of pragmatic trials is to mimic real-life scenarios and gain the highest level of validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can also be used to assess the causality of an intervention and its results. However, they shouldn't be used to substitute for the use of explanation trials.
The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace explanatory tests or if they should serve as an alternative to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool attempted to define the characteristics of a pragmatic study, including the recruitment process, the design and implementation of the intervention, and the follow-up.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. However, it is important to note that the majority of these studies were conducted in primary care settings.