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Studies designed to provide insight into clinical practice in the real world are referred to 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 routinely available equipment.
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A pragmatic study that involves different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for pragmatic trials to be reliable and reduce bias in results, is also necessary. However, too much heterogeneity can result in issues with the design of the trial.
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The goal of pragmatic trials is to mimic real-life scenarios and to achieve maximum validity externally. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They also provide a useful way to identify the causality between the intervention and its effects. However, they should not be used as a substitute for explanatory studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove a physiological or clinical hypothesis and pragmatic trials, which guide the policy and practice of. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a pragmatic trial, including recruitment, design and delivery of the intervention, as well as the follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority were conducted in primary care settings.
