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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 typically described as focusing on practical aspects of design which include the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and participants from various geographical areas. This type of heterogeneity is essential for practical trials to be valid and helps reduce the chance of bias in the results. However too much heterogeneity could result in issues with the design of the trial.
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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually commissioned by practitioners and policy makers to guide their decision-making. They can also be a great method to determine the causality between the intervention and its effects. They should not, however, be used to replace explanatory studies.
The pragmatism idea is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they should serve as an addition to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the elements of a practical trial that include the recruitment process, the design and implementation of the intervention, as well as the follow-up.
There is a positive trend in the number of 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 indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind, however, that the majority were conducted in primary-care settings.
