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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often described by their focus on practical aspects of study design which include recruitment and consent, adherence and the use routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and had participants from various geographical areas. This kind of heterogeneity, which is vital for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. Too much heterogeneity, however could cause issues with the trial design.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. Usually, they are commissioned by policymakers and practitioners in order to guide their decisions. They can also be used to determine the causal relationship between an intervention and its results. However, they should not be used in lieu for explanatory trials.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which support a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, as well as follow-up.
There is a growing increase in the number pragmatic trials that are published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. It is important to remember that the majority were conducted in primary-care settings.