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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 characterized by a focus on the practical aspects of the study design, including the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and had participants from various geographical areas. This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and also reduces bias in the results. However, too much heterogeneity can result in problems with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually requested by practitioners and policy makers to aid in their decision-making. They can also be used to assess the causal relationship between an intervention and its results. However, they should not be used to replace the need for explanation studies.
The idea of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace explanatory tests or if they are a complement to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a pragmatic study that include recruitment, design and delivery of the intervention, as well as the follow-up.
There is a growing increase in the number pragmatic trials published. A recent Medline search using the words pragmatic and naturalistic, limited 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 pragmatism. It is important to note, however, that the majority were conducted in primary-care settings.