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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often characterized by a focus on the practical aspects of the study design, such as the recruitment process and consent as well as adherence to the use of standard equipment.
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A pragmatic trial that uses a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also helps reduce bias in the results. A high degree of heterogeneity, however could cause issues with the design of the trial.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are usually requested by practitioners and policy makers to aid in their decision-making. They are also a good method to determine the causality between an intervention and its results. They should, however, not, be used to replace the need for explanation studies.
The pragmatism idea is controversial, and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove a physiological or clinical hypothesis and pragmatic trials, which inform the practice and policy decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the elements of a pragmatic study that include the recruitment process, the design and delivery of the intervention, as well as the follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs), yielded 34 articles, shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note that the majority of these trials were conducted in primary care settings.