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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically described by their focus on practical aspects of design that include the recruitment and consent process, as well as adherence and the use of standard equipment.
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A pragmatic trial that uses different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for practical trials to be valid, and it 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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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are typically commissioned by policy makers and practitioners to inform their decision making. They can also be used to determine the causality of an intervention and its effects. However, they should not be used to substitute for explanation trials.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform policy and practice decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic study that includes recruitment, design, implementation of the intervention and follow-up.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note, however, that the majority were conducted in primary-care settings.