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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often characterized as a focus on the practical aspects of design which include the recruitment process and consent, adhering and the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and included participants from different geographical regions. This kind of heterogeneity is required for pragmatic trials to be valid and also helps reduce the chance of bias in the results. However, too much heterogeneity could cause issues with the trial design.
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The goal of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. They are typically commissioned by practitioners and policy makers to inform their decision making. They are also a good method of determining the cause-effect relationship between the intervention and its effects. However, they shouldn't be used to substitute for 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 proposed a distinction between explanatory studies, which support the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool attempted to define the elements of a pragmatic study that include 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. They are displayed in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these trials were conducted in primary care settings.