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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are usually characterized by a focus on practical aspects of the study design, such as the recruitment and consent process as well as adherence to the use of routinely available equipment.
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A practical trial that employs a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and also helps to reduce the chance of bias in the results. However too much heterogeneity could result in problems with the design of the trial.
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The goal of pragmatic trials is to simulate real-life scenarios and gain maximum credibility externally. They are typically commissioned by practitioners and policy makers to inform their decision making. They can be used to determine the causality of an intervention with its outcomes. They should not, however, be used to replace explanation studies.
The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could be used to replace explanation tests or if they are an addition to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials that aid in the decision-making process for policy and practice. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the features of a pragmatic trial which includes the recruitment process, the design and implementation of the intervention, and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note that the majority of these studies were conducted in primary care settings.