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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of study design which include recruitment and consent, adherence and the use routinely available equipment.
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A pragmatic trial that uses different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity that is crucial for a pragmatic trial to be reliable and reduce bias in results, is also necessary. However, too much heterogeneity can cause issues with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life situations and achieve maximum validity externally. They are usually commissioned by practitioners and policy makers to guide their decision-making. They are also a good method to determine the causal relationship between the intervention and its effects. They should not, however, be used to replace explanatory studies.
The concept of pragmatism is controversial and there are concerns regarding whether pragmatic trials could be used to replace explanation tests or if they are a complement to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which support the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform policy and practice decision-making. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the elements of a practical trial that include the recruitment process, the design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted 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 remember, however, that the majority were conducted in primary-care settings.