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Pragmatic trials are trials designed to inform the real-world practice of clinical. They are often described by their focus on practical aspects of designing a study which include recruitment and consent, adherence and the use routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and had participants from various geographical areas. This type of heterogeneity, which is vital for pragmatic trials to be reliable and lessen the chance of bias, is also necessary. A high degree of heterogeneity, however could cause issues with the trial design.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are usually commissioned by policy makers and practitioners to inform their decision making. They can also be used to determine the causal relationship between an intervention with its outcomes. However, they should not be used in lieu for the use of explanation trials.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanation tests or if they are an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which support the physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic research study that includes recruitment, design, implementation of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is an indication that the health sciences community is becoming more acquaint to the subject of pragmatism. It is important to remember that the majority were conducted in primary-care settings.