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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often described as focusing on practical aspects of design that include the recruitment and consent process, as well as adherence and the use of standard equipment.
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A practical trial that employs a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for a pragmatic trial to be reliable and reduce bias in results, is also necessary. A high degree of heterogeneity, however can result in problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. Usually, they are commissioned by policymakers and practitioners to inform their decisions. They can be used to determine the causality of an intervention and its effects. They should not, however be used to replace explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should 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 policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic research study which includes recruitment, design, delivery of the intervention and its follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the subject of pragmatism. However, it is important to note that the majority of these trials were conducted in primary care settings.