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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, such as recruitment and consent as well as adherence to the use of standard equipment.
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A pragmatic trial that uses various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for a pragmatic trial to be valid and lessen the chance of bias, is also necessary. However too much heterogeneity could cause issues with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually requested by practitioners and policy makers to inform their decision making. They can also be used to determine the cause-effect relationship of an intervention and its results. They should, however, not be used to replace explanation studies.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials can be used to replace explanation tests or if they should be an addition to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which prove the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform policy and practice decision-making. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool was designed to define the elements of a pragmatic trial which includes the recruitment process, the design and implementation of the intervention, and the follow-up.
The number of pragmatic trials is increasing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind, however, that the majority of studies were conducted in primary care settings.