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Pragmatic trials are those that are designed to provide information for the real-world practice of clinical. They are often characterized as a focus on the practical aspects of design, including the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for a pragmatic trial to be reliable and to reduce bias in the results is also essential. A high degree of heterogeneity, however could cause issues with the trial design.
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The goal of pragmatic trials is to mimic real-life scenarios and to achieve the highest level of validity externally. They are usually commissioned by practitioners and policy makers to inform their decision making. They also provide a useful method of determining the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used in lieu for the use of explanation trials.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace tests for explanations or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis as well as pragmatic trials, which guide the policy and practice of. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the elements of a pragmatic trial which includes recruitment, design and delivery of the intervention, as well as the 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 indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to note that the majority of these studies were conducted in primary care settings.