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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, including recruitment and consent, adherence, and the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographic areas. This kind of heterogeneity is required for pragmatic trials to be valid and also helps to reduce the chance of bias in the results. Too much heterogeneity, however could cause issues with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. Usually, they are commissioned by policymakers and practitioners to guide their decisions. They also provide a useful method to determine the causality between an intervention and its outcomes. However, they should not be used to substitute for the use of explanation studies.
The pragmatism concept is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 made a distinction between explanatory studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform policy and practice decision-making. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the features of a pragmatic trial that include the recruitment process, the design and implementation of the intervention, as well as follow-up.
The number of pragmatic trials is growing. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary care settings.